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Early Bactericidal Activity (EBA) of SQ109 in Adult Subjects With Pulmonary TB

NCT01218217 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-01-14

No results posted yet for this study

Summary

SQ109 was developed with the aim of shortening TB treatment and providing new drugs for resistant TB. The drug has demonstrated efficacy in toxicology studies and an acceptable safety profile in first-in-man studies. The objective of this study is to evaluate the extended early bactericidal activity (EBA), safety, tolerability, and pharmacokinetics of several doses of SQ109 with or without Rifampicin (RIF) for 14 days in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB.

Conditions

  • Tuberculosis, Pulmonary

Interventions

DRUG

SQ109

SQ109 150 mg tablet

DRUG

Rifampicin

Rifampicin 150 mg capsules

Sponsors & Collaborators

  • Sequella, Inc.

    collaborator INDUSTRY

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Quintiles, Inc.

    collaborator INDUSTRY

  • CMed Technologies Inc.

    collaborator INDUSTRY

  • PathCare

    collaborator UNKNOWN

  • Parexel

    collaborator INDUSTRY

  • Michael Hoelscher

    lead OTHER

Principal Investigators

  • Michael Hoelscher, MD · Klinikum of the University of Munich

  • Andreas Diacon, MD · Task Applied Sciences

  • Rodney Dawson, MD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-09-30
Completion
2012-05-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218217 on ClinicalTrials.gov