Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB

PHASE2CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

March 29, 2022

Study Completion Date

March 29, 2022

Conditions
Tuberculosis, Multidrug-Resistant
Interventions
DRUG

Levofloxacin

Levofloxacin is a quinolone antibiotic used to treat lung, sinus, skin, and urinary tract infections caused by bacteria. The chemical name is (-)-(S)-9fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido\[1,2,3-de\]-1,4benzoxazine-6-carboxylic acid hemihydrate.

DRUG

Optimized background regimen (OBR)

"For this study OBR will mean optimized background regimen, not including a quinolone. OBR will be selected at the discretion of the study investigator to conform with standards of care and local site guidelines. In general, the OBR regimen should include at least 3 drugs (other than levofloxacin) to which the patient's isolate is not expected to be resistant, with one of these being an injectable agent, at the usual recommended doses."

Trial Locations (3)

Unknown

Partners in Health, Lima

University of Cayetana Heredia, Lima

Stellenbosch University, Cape Town

Sponsors
All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Centers for Disease Control and Prevention

FED

collaborator

Macleods Pharmaceuticals Ltd

INDUSTRY

lead

Boston University

OTHER

NCT01918397 - Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB | Biotech Hunter | Biotech Hunter