Tuberculosis, Multidrug-Resistant Clinical Trial
— DIAMAOfficial title:
Culture Free Diagnosis and Follow-up of Multidrug Resistant Tuberculosis Patients
NCT number | NCT03303963 |
Other study ID # | DRIA2014-326 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 4, 2017 |
Est. completion date | November 30, 2022 |
Verified date | March 2023 |
Source | Laboratoire de Référence des Mycobactéries |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin Resistant Tuberculosis (RR-TB) but only rifampicin resistance is diagnosed, leading to presumptive diagnosis of resistance to isoniazid and maybe other drugs. Thus in low and middle income countries, most drug sensitivity testing relies on phenotypic drug resistance testing, which takes up to 4 months. In addition, currently, culture on monthly sputum samples is recommended by the World Health Organization for follow-up of Rifampicin Resistant Tuberculosis patients under treatment. Unfortunately, culture is often not locally available and samples need to be transported from field to culture laboratories. The associated transport delays lead to high rates of contamination and false negative culture, particularly in laboratories in low resource settings. Many gaps for the diagnosis and management of RR-TB patients still need to be addressed and the DIAMA project (DIAgnostics for Multidrug resistant tuberculosis in Africa) study aims to address some of them.
Status | Completed |
Enrollment | 3356 |
Est. completion date | November 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | Inclusion criteria: - Being = 15 year old - Having a positive test on GeneXpert (M. tuberculosis) with or without resistance detected to rifampicin - Willing and able to provide written informed consent, or for minors: assent from and consent from a legal representative Exclusion Criteria: None |
Country | Name | City | State |
---|---|---|---|
Belgium | Institute of Tropical Medecine | Antwerp | |
Benin | Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou | Cotonou | Atlantique/Littoral |
Cameroon | The Tuberculosis Reference Laboratory Bamenda | Bamenda | |
Congo, The Democratic Republic of the | Institut National de Recherche Biomédicale (INRB) | Kinshasa | |
Ethiopia | Jimma University | Jima | |
Guinea | Service de Pneumophtisiologie, Hôpital Ignace Deen, Conakry | Conakry | |
Mali | Université des Sciences, des Techniques et des Technologies de Bamako, SEREFO | Bamako | |
Nigeria | Damien Fundation | Ibadan | |
Rwanda | Rwanda Biomedical Center (RBC) | Kigali | |
Senegal | Université Cheick Anta Diop (UCAD) | Dakar |
Lead Sponsor | Collaborator |
---|---|
Dissou AFFOLABI | Cheikh Anta Diop University, Senegal, Damien Foundation, Genoscreen, Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, Institute of Tropical Medicine, Belgium, Jimma University, London School of Hygiene and Tropical Medicine, Rwanda Biomedical Centre, Service de Pneumophtisiologie, Hôpital Ignace Deen, The Tuberculosis Reference Laboratory Bamenda, University of the Sciences, Techniques and Technologies of Bamako, World Health Organization |
Belgium, Benin, Cameroon, Congo, The Democratic Republic of the, Ethiopia, Guinea, Mali, Nigeria, Rwanda, Senegal,
Aung KJ, Van Deun A, Declercq E, Sarker MR, Das PK, Hossain MA, Rieder HL. Successful '9-month Bangladesh regimen' for multidrug-resistant tuberculosis among over 500 consecutive patients. Int J Tuberc Lung Dis. 2014 Oct;18(10):1180-7. doi: 10.5588/ijtld. — View Citation
Bastos ML, Hussain H, Weyer K, Garcia-Garcia L, Leimane V, Leung CC, Narita M, Pena JM, Ponce-de-Leon A, Seung KJ, Shean K, Sifuentes-Osornio J, Van der Walt M, Van der Werf TS, Yew WW, Menzies D; Collaborative Group for Meta-analysis of Individual Patien — View Citation
Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1. — View Citation
Piubello A, Harouna SH, Souleymane MB, Boukary I, Morou S, Daouda M, Hanki Y, Van Deun A. High cure rate with standardised short-course multidrug-resistant tuberculosis treatment in Niger: no relapses. Int J Tuberc Lung Dis. 2014 Oct;18(10):1188-94. doi: — View Citation
Van Deun A, Maug AK, Salim MA, Das PK, Sarker MR, Daru P, Rieder HL. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2010 Sep 1;182(5):684-92. doi: 10.1164/rccm.201001-0077OC. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validation of Deeplex test | Concordance between phenotypic Drug Susceptibility Test, WGS and Deeplex results | 4 years | |
Primary | Validation of GeneXpert 2nd line | Concordance between WGS, Deeplex results and GeneXpert 2nd line results | 4 years | |
Primary | Validation of MolBio TrueNat for INH, FQ and BDQ | Concordance between WGS, Deeplex results and MolBioTrueNat results | 4 years | |
Primary | Validation of FDA microscopy | Concordance between Culture results and FDA microscopy results | 4 years | |
Primary | Validation of GeneXpert Ct value | Concordance between Culture results and GeneXpert Ct value results | 4 years | |
Secondary | Estimation of proportion of additional resistance in patients resistant to Rifampicin | Evaluation to be done with the Deeplex test | 4 years | |
Secondary | Measurement of the association of specific mutations against some drugs with programmatic treatment outcome | Evaluation to be done with the Deeplex test | 4 years | |
Secondary | Evaluation of the add value of Connectivity system in the management of Multi Drug Resistant-Tuberculosis patients | Evaluation to be done with Data2Care connectivity system | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05871489 -
Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens
|
||
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Active, not recruiting |
NCT04179500 -
A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis Volunteers
|
Phase 2 | |
Completed |
NCT03086486 -
Various Doses and Durations of Linezolid Plus Bedaquiline & Pretomanid in Participants With Drug Resistant Tuberculosis
|
Phase 3 | |
Completed |
NCT01201941 -
Operational Assessment of Laboratory Information System for MDR-TB in Lima, Peru
|
N/A | |
Not yet recruiting |
NCT06441006 -
Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis
|
Phase 3 | |
Completed |
NCT02413931 -
Nosocomial Transmission of MDR-TB in Bucharest, Romania
|
||
Recruiting |
NCT05306223 -
A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
|
Phase 4 | |
Completed |
NCT02573350 -
A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
|
Phase 2 | |
Completed |
NCT02597621 -
Biomarkers for Therapy Response in Drug-resistant Tuberculosis
|
||
Recruiting |
NCT05555303 -
Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis
|
Phase 2 | |
Recruiting |
NCT03828201 -
Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine to Treat MDR-TB
|
Phase 2 | |
Recruiting |
NCT01212003 -
Training Protocol on the Natural History of Tuberculosis
|
||
Terminated |
NCT03237182 -
The Individualized M(X) Drug-resistant TB Treatment Strategy Study
|
Phase 4 | |
Completed |
NCT03338621 -
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05007795 -
Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis
|
N/A | |
Completed |
NCT03728725 -
Xpert MTB/XDR Clinical Evaluation Trial
|
||
Completed |
NCT02589782 -
Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)
|
Phase 2/Phase 3 | |
Recruiting |
NCT02619994 -
Treatment Shortening of MDR-TB Using Existing and New Drugs
|
Phase 2 | |
Completed |
NCT01918397 -
Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB
|
Phase 2 |