NIMR - Mbeya Medical Research Programme

Quick Information

NIMR - Mbeya Medical
Research Center

P.O Box 2410
Hospital Hill rd, Mbeya Tanzania

Tel    +255 25 250 3364
Fax   +255 25 250 3134
Working hours:
Mon   -  Fri
08:00 - 16:30 EAT (GMT + 3)

Drug Trials

The OEBA Study: Observation of Early Bactericidal Activity of Standard TB Treatment

A PanACEA Capacity Development Project

MMRC: Site Principal Investigator: Andrea Rachow, MD, Co-Site PI: Issa Sabi

Munich: Protocol Chair: Norbert Heinrich

Purpose
Early Bactericidal Activity (EBA) Studies are currently the eye of the needle in the anti-TB drug development process, with limited site capacity slowing down phase 2 testing of new anti-TB drug candidates. To address this problem, PanACEA (Pan-African Consortium for Evaluation of Antituberculosis Antibiotics) has decided to develop a Tanzanian EBA facility consisting of MMRC and Kilimanjaro Clinical Research Institute (KCRI).

OEBA is designed as a platform to establish capacity for Early Bactericidal Activity Studies in these sites, and will provide the opportunity to research additional questions around TB treatment and monitoring of treatment success.

Approach
The sites are developing their inpatient facilities, train laboratory and clinical staff, and demonstrate the capabilities within this two-site study, which will apply the methodologies to patients newly started on standard anti-TB treatment. The results of this study will demonstrate that EBA studies are feasible in the two-site setting in Tanzania.

Results
Tthe protocol has been finalized in 3Q 2010, and is currently undergoing ethical review.

Sponsors
Tthe study is sponsored by the European and Developing Countries Clinical Trials Partnership (EDCTP), within the PanACEA capacity development plan.

Partners
Kilimanjaro Clinical Research Institute, Radboud University Nijmegen, the Netherlands, University College of London

Publications
no publications yet

 

PanACEA SQ 109

Chief Investigator: Dr. M. Hoelscher, MD, PhD, Associate Professor

Project Coordinator: S. Henne, MSc

Medical Expert: Dr. N. Heinrich, MD

Description:

Within the newly founded PanACEA Consortium, three European universities (LMU, University College of London, University St.Radboud, Nijmegen, the Netherlands)  are collaborating with 10 African study sites to accelerate clinical development of new anti-tuberculosis drugs, meeting international quality standards.
The working group has played a role in initiating this consortium, and is responsible for clinical development (phase II) of the drug candidate SQ109.

SQ109 was developed by Sequella, Inc., and exhibited good activity against tuberculosis in animal models, as well as good tolerability when given to healthy volunteers. Further testing of the drug candidate for its efficacy in human tuberculosis will be performed within a public-private-partnership in Africa. Study design and study coordination will be done by Dr Hoelscher and his working group.

International multicenter trials are planned to be carried out in South Africa, Zambia, Tanzania, and Gabon. International standards for quality and ethical study conduct (Good Clinical Practice, Declaration of Helsinki) will be met, to ensure protection of human study subjects.

 

REMoxTB

This is a randomised placebo – controlled double blind trial comparing two treatment shortening regimens with the standard regimen (two months ethambutol, isoniazid, rifampicin and pyrazinamide followed by four months isoniazid and rifampicin) namely 1) two months moxifloxacin, isoniazid, rifampicin and pyrazinamide followed by two months moxifloxacin, isoniazid and rifampicin and 2) two months ethambutol, moxifloxacin, rifampicin and pyrazinamide followed by two months moxifloxacin and rifampicin for the treatment of adults with pulmonary tuberculosis.

Team
MMRC: Dr. Leonard Maboko (site principal investigator), Dr. Chacha Mangu (clinical research coordinator, study clinician), Dr. Andrea Rachow (study coordinator), Dr. Issa Sabi (study clinician), Dr. Denis Ngatemelela (study clinician), Ruth Bakuza (study secretary), Sophie Hyera (counsellor, medical officer), Magreth Sembo (counsellor, medical officer), Jane Abindwhile (social scientist), Revocatus Kunambi (pharmacist), Theopista Lotto (back-up pharmacist), Dickens Kuwour (senior data manager), Sosten Buromo (senior data entry officer), Happy Shimwela (driver), Patrick Hamisi Chaula (driver), Rahabu Mkandawile (courier).

LMU: Dr. Michael Hoelscher (scientific director), Dr. Norbert Heinrich (study coordinator), Bettina Rademacher (head of project administration and finance).

Purpose
The commonly used drugs to treat tuberculosis are rifampicin, isoniazid, ethambutol and pyrazinamide. Standard therapy consists of a combination of all four drugs for 2 months followed by a 4 months period of rifampicin and isoniazid combined. Previous studies in animals and in humans suggest that a new drug called moxifloxacin may also be an effective treatment in tuberculosis.  Moreover, promising laboratory studies on mice suggest that moxifloxacin may enable the total duration of chemotherapy to be reduced to four months, which would be a significant improvement for patients taking medication for tuberculosis.

Approach
REMoxTB is a randomised placebo – controlled double blind trial comparing two treatment shortening regimens with the standard regimen (two months ethambutol, isoniazid, rifampicin and pyrazinamide followed by four months isoniazid and rifampicin) namely 1) two months moxifloxacin, isoniazid, rifampicin and pyrazinamide followed by two months moxifloxacin, isoniazid and rifampicin and 2) two months ethambutol, moxifloxacin, rifampicin and pyrazinamide followed by two months moxifloxacin and rifampicin for the treatment of adults with pulmonary tuberculosis. 
Patients selected for the study will be allocated to one of three treatment groups.  The first group will be given six months standard treatment.  A second group will receive moxifloxacin substituted for ethambutol, as part of a four month regimen, to see whether the shorter treatment is as effective as the standard six month treatment.  The third group will receive moxifloxacin substituted for isoniazid, as part of a four month regimen, to see whether the shorter treatment is as effective as the standard six month treatment.  
During and after receiving study treatment the study patients are reviewed for adverse events and clinical outcome. Sputum samples are collected at each study visit for preparation of sputum smear and culture and other investigations (e.g. treatment marker). The follow up period lasts for 12 months after finishing of study treatment.

Results
Since the study is still ongoing final results are not yet available.

Sponsor
This worldwide multicenter phase 3 treatment trial is sponsored by the EDCTP and Global TB Alliance.

Partners

1. Pan African Consortium for Evaluation of Anti TB Treatment (PanACEA), founded by three European universities (Ludwig Maximilian University, Munich in Germany, University College of London Great Britain, University St. Radboud, Nijmegen in the Netherlands) who are collaborating with 10 African study sites to accelerate clinical development of new anti-tuberculosis drugs, meeting international quality standards.

2. Global TB-Alliance

3. Triclinium, Clinical Trial Project Management (PTY) LTD

Publications
N/A

 

 

 

 

Azythormicin .....

Get details from Leonard for this project

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