An observational study in Multi-drug Resistant Tuberculosis, sponsored by Centre de Recherche Médicale de Lambaréné. Completed at 1 site in Gabon. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Centre de Recherche Médicale de Lambaréné · Observational
The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.
Study participants will be followed up, under existing protocol derived from a study protocol developed by the "Union internationale contre les maladies respiratoires" and carried out already in 9 Africans countries. Participants will be hospitalised for at least four month, period which they will be given treatments, assessed for adverse events, monitored for TB-MR strains using culture techniques, at the monthly basis. If patients found with negative sputum culture at month four they will be dischrged from the hospital, and then treated four an additional five montns and then follow up, clinically and biologically for an additional six months before being declared as cured.
132 studies on the registry are indexed under Tuberculosis, Multidrug-Resistant; 25 are open to participants now.
This study's enrollment of 23 is below the median of 410 across 42 observational studies indexed under Tuberculosis, Multidrug-Resistant.
Browse Tuberculosis, Multidrug-Resistant studies →Centre de Recherche Médicale de Lambaréné is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
study population will consist of all consecutive patients with bacteriologically proven MDR-TB who fulfil the inclusion criteria .
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients older than 15 years old receiving Km+ Mfx+ Pto + H + Cfz +E+Z
Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z
Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide
cure rate post treatment
Proportion of participants alive and presented with negative sputum culture for TB and with the absence of clinical, X-Ray and biological disorders related to TB
Time frame: Six months post treatment
TB-culture
First TB culture negative time
Time frame: 4 months after start of the treatment
Regimen tolorability
treatment, safety through clinical and biological assessment
Time frame: Throughout treatment period (9months)
Adverse events
solicited and unsolicited adverse events
Time frame: duration of participant in the study (15months)
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Tuberculosis, Multidrug-Resistant →
Centre de Recherche Médicale de Lambaréné