Safety, effectiveness, and adherence of a short and all-oral treatment regimen for the treatment of rifampicin-resistant tuberculosis in Niger: a study protocol of a pragmatic randomised clinical trial with stratified block randomisation
Background Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-li...
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| Published in: | Current controlled trials in cardiovascular medicine Vol. 23; no. 1; pp. 1011 - 14 |
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| Main Authors: | , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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BioMed Central
13.12.2022
BioMed Central Ltd Springer Nature B.V BMC |
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| ISSN: | 1745-6215, 1745-6215 |
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| Abstract | Background
Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-line injectable drug (SLID)-containing Short Treatment Regimen (STR), with linezolid replacing the SLID in patients with ototoxicity. Given the availability of novel anti-tuberculosis drugs, WHO recommends all-oral RR-TB treatment. Considering the high level of success with the Niger treatment strategy, it would only be justified to replace it in case robust evidence shows that the WHO all-oral bedaquiline/linezolid (BDQ/LZD)-containing STR (experimental arm) performs better than the Niger RR-TB treatment strategy, (control arm) in terms of safety, effectiveness and adherence.
Methods
A pragmatic randomised clinical trial (RCT) using stratified block randomisation, conducted between April 2021 and March 2024, prospectively enrols participants diagnosed with RR-TB in one of the four RR-TB units of the nation. Depending of the month in which patients are diagnosed with RR-TB, patients with FQ-susceptible RR-TB are enrolled in either the experimental arm or control arm.
Discussion
To increase the feasibility of conducting a RCT, embedded in routine activities of all Niger’s RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of the clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-base on how to develop robust RR-TB treatment regimens.
Trial registration
Pan African Clinical Trial Register
PACTR202203645724919
. Registered on 15 March 2022. |
|---|---|
| AbstractList | Abstract Background Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-line injectable drug (SLID)-containing Short Treatment Regimen (STR), with linezolid replacing the SLID in patients with ototoxicity. Given the availability of novel anti-tuberculosis drugs, WHO recommends all-oral RR-TB treatment. Considering the high level of success with the Niger treatment strategy, it would only be justified to replace it in case robust evidence shows that the WHO all-oral bedaquiline/linezolid (BDQ/LZD)-containing STR (experimental arm) performs better than the Niger RR-TB treatment strategy, (control arm) in terms of safety, effectiveness and adherence. Methods A pragmatic randomised clinical trial (RCT) using stratified block randomisation, conducted between April 2021 and March 2024, prospectively enrols participants diagnosed with RR-TB in one of the four RR-TB units of the nation. Depending of the month in which patients are diagnosed with RR-TB, patients with FQ-susceptible RR-TB are enrolled in either the experimental arm or control arm. Discussion To increase the feasibility of conducting a RCT, embedded in routine activities of all Niger’s RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of the clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-base on how to develop robust RR-TB treatment regimens. Trial registration Pan African Clinical Trial Register PACTR202203645724919 . Registered on 15 March 2022. Background Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-line injectable drug (SLID)-containing Short Treatment Regimen (STR), with linezolid replacing the SLID in patients with ototoxicity. Given the availability of novel anti-tuberculosis drugs, WHO recommends all-oral RR-TB treatment. Considering the high level of success with the Niger treatment strategy, it would only be justified to replace it in case robust evidence shows that the WHO all-oral bedaquiline/linezolid (BDQ/LZD)-containing STR (experimental arm) performs better than the Niger RR-TB treatment strategy, (control arm) in terms of safety, effectiveness and adherence. Methods A pragmatic randomised clinical trial (RCT) using stratified block randomisation, conducted between April 2021 and March 2024, prospectively enrols participants diagnosed with RR-TB in one of the four RR-TB units of the nation. Depending of the month in which patients are diagnosed with RR-TB, patients with FQ-susceptible RR-TB are enrolled in either the experimental arm or control arm. Discussion To increase the feasibility of conducting a RCT, embedded in routine activities of all Niger's RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of the clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-base on how to develop robust RR-TB treatment regimens. Trial registration Pan African Clinical Trial Register PACTR202203645724919. Registered on 15 March 2022. Keywords: Rifampicin resistance tuberculosis, All oral treatment, New anti-tuberculosis drugs, Niger Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-line injectable drug (SLID)-containing Short Treatment Regimen (STR), with linezolid replacing the SLID in patients with ototoxicity. Given the availability of novel anti-tuberculosis drugs, WHO recommends all-oral RR-TB treatment. Considering the high level of success with the Niger treatment strategy, it would only be justified to replace it in case robust evidence shows that the WHO all-oral bedaquiline/linezolid (BDQ/LZD)-containing STR (experimental arm) performs better than the Niger RR-TB treatment strategy, (control arm) in terms of safety, effectiveness and adherence.BACKGROUNDRifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-line injectable drug (SLID)-containing Short Treatment Regimen (STR), with linezolid replacing the SLID in patients with ototoxicity. Given the availability of novel anti-tuberculosis drugs, WHO recommends all-oral RR-TB treatment. Considering the high level of success with the Niger treatment strategy, it would only be justified to replace it in case robust evidence shows that the WHO all-oral bedaquiline/linezolid (BDQ/LZD)-containing STR (experimental arm) performs better than the Niger RR-TB treatment strategy, (control arm) in terms of safety, effectiveness and adherence.A pragmatic randomised clinical trial (RCT) using stratified block randomisation, conducted between April 2021 and March 2024, prospectively enrols participants diagnosed with RR-TB in one of the four RR-TB units of the nation. Depending of the month in which patients are diagnosed with RR-TB, patients with FQ-susceptible RR-TB are enrolled in either the experimental arm or control arm.METHODSA pragmatic randomised clinical trial (RCT) using stratified block randomisation, conducted between April 2021 and March 2024, prospectively enrols participants diagnosed with RR-TB in one of the four RR-TB units of the nation. Depending of the month in which patients are diagnosed with RR-TB, patients with FQ-susceptible RR-TB are enrolled in either the experimental arm or control arm.To increase the feasibility of conducting a RCT, embedded in routine activities of all Niger's RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of the clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-base on how to develop robust RR-TB treatment regimens.DISCUSSIONTo increase the feasibility of conducting a RCT, embedded in routine activities of all Niger's RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of the clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-base on how to develop robust RR-TB treatment regimens.Pan African Clinical Trial Register PACTR202203645724919 . Registered on 15 March 2022.TRIAL REGISTRATIONPan African Clinical Trial Register PACTR202203645724919 . Registered on 15 March 2022. Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-line injectable drug (SLID)-containing Short Treatment Regimen (STR), with linezolid replacing the SLID in patients with ototoxicity. Given the availability of novel anti-tuberculosis drugs, WHO recommends all-oral RR-TB treatment. Considering the high level of success with the Niger treatment strategy, it would only be justified to replace it in case robust evidence shows that the WHO all-oral bedaquiline/linezolid (BDQ/LZD)-containing STR (experimental arm) performs better than the Niger RR-TB treatment strategy, (control arm) in terms of safety, effectiveness and adherence. A pragmatic randomised clinical trial (RCT) using stratified block randomisation, conducted between April 2021 and March 2024, prospectively enrols participants diagnosed with RR-TB in one of the four RR-TB units of the nation. Depending of the month in which patients are diagnosed with RR-TB, patients with FQ-susceptible RR-TB are enrolled in either the experimental arm or control arm. To increase the feasibility of conducting a RCT, embedded in routine activities of all Niger's RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of the clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-base on how to develop robust RR-TB treatment regimens. Pan African Clinical Trial Register PACTR202203645724919 . Registered on 15 March 2022. Background Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-line injectable drug (SLID)-containing Short Treatment Regimen (STR), with linezolid replacing the SLID in patients with ototoxicity. Given the availability of novel anti-tuberculosis drugs, WHO recommends all-oral RR-TB treatment. Considering the high level of success with the Niger treatment strategy, it would only be justified to replace it in case robust evidence shows that the WHO all-oral bedaquiline/linezolid (BDQ/LZD)-containing STR (experimental arm) performs better than the Niger RR-TB treatment strategy, (control arm) in terms of safety, effectiveness and adherence. Methods A pragmatic randomised clinical trial (RCT) using stratified block randomisation, conducted between April 2021 and March 2024, prospectively enrols participants diagnosed with RR-TB in one of the four RR-TB units of the nation. Depending of the month in which patients are diagnosed with RR-TB, patients with FQ-susceptible RR-TB are enrolled in either the experimental arm or control arm. Discussion To increase the feasibility of conducting a RCT, embedded in routine activities of all Niger’s RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of the clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-base on how to develop robust RR-TB treatment regimens. Trial registration Pan African Clinical Trial Register PACTR202203645724919 . Registered on 15 March 2022. BackgroundRifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-line injectable drug (SLID)-containing Short Treatment Regimen (STR), with linezolid replacing the SLID in patients with ototoxicity. Given the availability of novel anti-tuberculosis drugs, WHO recommends all-oral RR-TB treatment. Considering the high level of success with the Niger treatment strategy, it would only be justified to replace it in case robust evidence shows that the WHO all-oral bedaquiline/linezolid (BDQ/LZD)-containing STR (experimental arm) performs better than the Niger RR-TB treatment strategy, (control arm) in terms of safety, effectiveness and adherence.MethodsA pragmatic randomised clinical trial (RCT) using stratified block randomisation, conducted between April 2021 and March 2024, prospectively enrols participants diagnosed with RR-TB in one of the four RR-TB units of the nation. Depending of the month in which patients are diagnosed with RR-TB, patients with FQ-susceptible RR-TB are enrolled in either the experimental arm or control arm.DiscussionTo increase the feasibility of conducting a RCT, embedded in routine activities of all Niger’s RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of the clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-base on how to develop robust RR-TB treatment regimens.Trial registrationPan African Clinical Trial Register PACTR202203645724919. Registered on 15 March 2022. Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not much more than 60% treatment success. In Niger, a high cure rate was obtained with a RR-TB treatment strategy based on a second-line injectable drug (SLID)-containing Short Treatment Regimen (STR), with linezolid replacing the SLID in patients with ototoxicity. Given the availability of novel anti-tuberculosis drugs, WHO recommends all-oral RR-TB treatment. Considering the high level of success with the Niger treatment strategy, it would only be justified to replace it in case robust evidence shows that the WHO all-oral bedaquiline/linezolid (BDQ/LZD)-containing STR (experimental arm) performs better than the Niger RR-TB treatment strategy, (control arm) in terms of safety, effectiveness and adherence. A pragmatic randomised clinical trial (RCT) using stratified block randomisation, conducted between April 2021 and March 2024, prospectively enrols participants diagnosed with RR-TB in one of the four RR-TB units of the nation. Depending of the month in which patients are diagnosed with RR-TB, patients with FQ-susceptible RR-TB are enrolled in either the experimental arm or control arm. To increase the feasibility of conducting a RCT, embedded in routine activities of all Niger's RR-TB Units, we used a creative trial design. We randomised by monthly blocks, whereby the regimen used changes every month, using the month of RR-TB diagnosis as stratifying variable. This approach was deemed feasible for Niger's national tuberculosis programme, as it simplifies the work of the clinicians running the RR-TB units. Our creative design may serve as an example for other national programs. Findings will inform national and international RR-TB treatment guidelines, and will also strengthen the evidence-base on how to develop robust RR-TB treatment regimens. |
| ArticleNumber | 1011 |
| Audience | Academic |
| Author | Decroo, Tom Gagara-Issoufou, Assiatou Van Deun, Armand Halidou-Moussa, Souleymane Mamadou, Saïdou Piubello, Alberto Ortuño-Gutiérrez, Nimer Adehossi, Eric Souleymane, Mahamadou Bassirou Maman Lawan, Ibrahim Soumana, Alphazazi |
| Author_xml | – sequence: 1 givenname: Mahamadou Bassirou surname: Souleymane fullname: Souleymane, Mahamadou Bassirou email: bachirsoul@gmail.com organization: Damien Foundation – sequence: 2 givenname: Tom surname: Decroo fullname: Decroo, Tom organization: Institute of Tropical Medicine, Research Foundation Flanders – sequence: 3 givenname: Alphazazi surname: Soumana fullname: Soumana, Alphazazi organization: Programme National de Lutte contre la Tuberculose, Programme – sequence: 4 givenname: Ibrahim surname: Maman Lawan fullname: Maman Lawan, Ibrahim organization: Damien Foundation – sequence: 5 givenname: Assiatou surname: Gagara-Issoufou fullname: Gagara-Issoufou, Assiatou organization: Université Abdou Moumouni de Niamey, Faculté des Science de la Santé – sequence: 6 givenname: Souleymane surname: Halidou-Moussa fullname: Halidou-Moussa, Souleymane organization: Hopital National Amirou Boubacar Diallo, Pneumo-phtysiologie – sequence: 7 givenname: Nimer surname: Ortuño-Gutiérrez fullname: Ortuño-Gutiérrez, Nimer organization: Damien Foundation – sequence: 8 givenname: Eric surname: Adehossi fullname: Adehossi, Eric organization: Université Abdou Moumouni de Niamey, Faculté des Science de la Santé – sequence: 9 givenname: Saïdou surname: Mamadou fullname: Mamadou, Saïdou organization: Université Abdou Moumouni de Niamey, Faculté des Science de la Santé – sequence: 10 givenname: Armand surname: Van Deun fullname: Van Deun, Armand organization: Independent Consultant – sequence: 11 givenname: Alberto surname: Piubello fullname: Piubello, Alberto organization: Damien Foundation, Damien Foundation |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/36514153$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.5588/IJTLD.17.0660 10.1186/s12879-018-3636-1 10.1016/j.rmed.2019.105844 10.1016/S1473-3099(21)00470-9 10.1164/RCCM.201001-0077OC 10.4103/ijmr.IJMR_579_19 10.3390/jcm9010055 10.5588/IJTLD.20.0217 10.1183/13993003.02250-2020 10.5588/ijtld.13.0075 10.1371/journal.pmed.1002767 10.1186/s13063-017-2292-x 10.5588/IJTLD.14.0535 10.1186/1472-6963-14-81 10.1016/S2213-2600(20)30047-3 10.1093/CID/CIAB335 |
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| Keywords | New anti-tuberculosis drugs All oral treatment Niger Rifampicin resistance tuberculosis |
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| PublicationTitle | Current controlled trials in cardiovascular medicine |
| PublicationTitleAbbrev | Trials |
| PublicationTitleAlternate | Trials |
| PublicationYear | 2022 |
| Publisher | BioMed Central BioMed Central Ltd Springer Nature B.V BMC |
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| References | 6912_CR7 6912_CR8 6912_CR3 JCM Brust (6912_CR14) 2021; 73 I Wrohan (6912_CR9) 2021; 25 A Van Deun (6912_CR16) 2018; 22 World Health Organization (WHO) (6912_CR1) 2014 TC Bouton (6912_CR20) 2017; 18 C Kuaban (6912_CR6) 2015; 19 A. nationale de recherche sur le S. et les hepatites Virales (6912_CR19) 2003 Z Lan (6912_CR10) 2020; 8 World Health Organization (WHO) (6912_CR2) 2016 FO Bada (6912_CR17) 2019; 19 S Horter (6912_CR18) 2014; 14 NA Ismail (6912_CR13) 2022; 22 6912_CR11 A Piubello (6912_CR5) 2014; 18 PPJ Phillips (6912_CR21) 2019; 16 6912_CR15 A Van Deun (6912_CR4) 2010; 182 World Health Organization (6912_CR12) 2020 |
| References_xml | – volume: 22 start-page: 239 issue: 3 year: 2018 ident: 6912_CR16 publication-title: Int J Tuberc Lung Dis doi: 10.5588/IJTLD.17.0660 – volume: 19 start-page: 1 issue: 1 year: 2019 ident: 6912_CR17 publication-title: BMC Infect Dis doi: 10.1186/s12879-018-3636-1 – volume-title: ANRS scale to grade the severity of adverse events in adults. Version n.1.0-2008 (Translation of the French version n.6 – 2003) year: 2003 ident: 6912_CR19 – ident: 6912_CR8 doi: 10.1016/j.rmed.2019.105844 – volume: 22 start-page: 496 issue: 4 year: 2022 ident: 6912_CR13 publication-title: Lancet Infect Dis doi: 10.1016/S1473-3099(21)00470-9 – volume: 182 start-page: 684 issue: 5 year: 2010 ident: 6912_CR4 publication-title: Am J Respir Crit Care Med doi: 10.1164/RCCM.201001-0077OC – volume-title: Global tuberculosis report year: 2016 ident: 6912_CR2 – ident: 6912_CR11 doi: 10.4103/ijmr.IJMR_579_19 – ident: 6912_CR7 doi: 10.3390/jcm9010055 – volume: 25 start-page: 23 issue: 1 year: 2021 ident: 6912_CR9 publication-title: Int J Tuberc Lung Dis doi: 10.5588/IJTLD.20.0217 – ident: 6912_CR15 doi: 10.1183/13993003.02250-2020 – volume: 18 start-page: 1188 issue: 10 year: 2014 ident: 6912_CR5 publication-title: Int J Tuberc Lung Dis doi: 10.5588/ijtld.13.0075 – ident: 6912_CR3 – volume: 16 start-page: 1 issue: 3 year: 2019 ident: 6912_CR21 publication-title: PLoS Med doi: 10.1371/journal.pmed.1002767 – volume: 18 start-page: 1 issue: 1 year: 2017 ident: 6912_CR20 publication-title: Trials doi: 10.1186/s13063-017-2292-x – volume: 19 start-page: 517 issue: 5 year: 2015 ident: 6912_CR6 publication-title: Int J Tuberc Lung Dis doi: 10.5588/IJTLD.14.0535 – volume-title: Companion handbook year: 2014 ident: 6912_CR1 – volume-title: WHO consolidated guidelines on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment year: 2020 ident: 6912_CR12 – volume: 14 start-page: 1 issue: 1 year: 2014 ident: 6912_CR18 publication-title: BMC Health Serv Res doi: 10.1186/1472-6963-14-81 – volume: 8 start-page: 383 issue: 4 year: 2020 ident: 6912_CR10 publication-title: Lancet Respir Med doi: 10.1016/S2213-2600(20)30047-3 – volume: 73 start-page: 2083 issue: 11 year: 2021 ident: 6912_CR14 publication-title: Clin Infect Dis doi: 10.1093/CID/CIAB335 |
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Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally... Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally results in not... Background Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally... BackgroundRifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and globally... Abstract Background Rifampicin-resistant tuberculosis (RR-TB) treatment requires combination treatment, which frequently causes serious adverse events and... |
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| SubjectTerms | All oral treatment Antitubercular agents Antitubercular Agents - adverse effects Audiometry Biomedicine Care and treatment Clinical trials Contraindications Corporate sponsorship Diagnosis Dosage and administration Drugs Evaluation Health Sciences Hearing loss Humans Informed consent Laboratories Linezolid - adverse effects Medicine Medicine & Public Health New anti-tuberculosis drugs Niger Patient compliance Patient outcomes Patients Randomized Controlled Trials as Topic Rifampicin resistance tuberculosis Rifampin - adverse effects Statistics for Life Sciences Study Protocol Success Testing Tuberculosis Tuberculosis, Multidrug-Resistant - diagnosis Tuberculosis, Multidrug-Resistant - drug therapy Tuberculosis, Pulmonary - diagnosis |
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| Title | Safety, effectiveness, and adherence of a short and all-oral treatment regimen for the treatment of rifampicin-resistant tuberculosis in Niger: a study protocol of a pragmatic randomised clinical trial with stratified block randomisation |
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