Evaluating a new treatment regimen for patients with multidrug-resistant TB (MDR-TB) - a randomised controlled Phase 3 trial.

university of Cape Town Lung Institute0 sites256 target enrollmentJuly 2, 2014

Overview

No summary available.

Registry

who.int

Start Date

July 2, 2014

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

university of Cape Town Lung Institute

•¿Provide written, informed consent prior to all trial\-related procedures including HIV testing.
•¿Male or female, aged 18 years and older.
•¿Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive.
•¿Newly diagnosed culture and/or GeneXpert positive pulmonary TB.
•¿GeneXpert rifampicin resistance confirmed on an alternative method of susceptibility testing (line probe assay (LPA) or phenotypic DST using a culture isolate or sputum sample.
•¿Ability to produce an adequate volume of sputum as estimated from a spot assessment (estimated 10 ml or more overnight production).
•¿Women of non\-childbearing potential or using effective methods of birth control.

•¿Previous history of treatment for MDR\-TB.
•¿Having received any drug active against MDR\-TB within 3 months or less prior to enrolment.
•¿Having been on treatment for drug sensitive TB treatment within 3 months or less prior to enrolment.
•¿Currently on MDR\-TB treatment for more than 2 weeks.
•¿Fluoroquinolone\-resistant and/or aminoglycoside\-resistant TB detected (pre\-XDR and XDR\-TB).
•¿Rifampicin mono\-resistance.
•¿Incompatibility between microbiological and clinic\-radiological findings (i.e. where the clinico\-radiological findings do not confirm the positive microbiological testing)
•¿Primarily extra\-thoracic TB as judged by the investigator.
•¿History of allergy to any of the trial IMP/s or related substances.
•¿Known or suspected, current alcohol or drug abuse, that is, in the opinion of the Investigator, sufficient to compromise the safety or cooperation of the participant.