NCT00216333

Brief Summary

The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding adherence and facilitating directly observed treatment. Recent bioavailability studies of four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing the efficacy of this compound, when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by four months treatment with a two-drug FDC of rifampicin and isoniazid.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_4

Geographic Reach
9 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 13, 2006

Status Verified

September 1, 2006

First QC Date

September 20, 2005

Last Update Submit

September 12, 2006

Conditions

Tuberculosis

Keywords

tuberculosisfixed dose combinationDOTshot-course chemotherapy

Outcome Measures

Primary Outcomes (2)

  • Efficacy : combined rate of failure at the end of treatment and relapse by 30 months.

  • Safety : occurrence of serious adverse events at any time during chemotherapy

Secondary Outcomes (2)

  • Sputum culture results at two months of chemotherapy

  • Rate of completion of chemotherapy according to the protocol

Interventions

combined fixed dose combinationDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly diagnosed pulmonary tuberculosis
  • two sputum specimens positive for acid-fast bacilli on direct smear microscopy
  • no previous anti-tuberculosis chemotherapy
  • aged 18 years and over
  • firm home address that is readily accessible for visiting for the duration of the trial (including follow up period)
  • agree to participate in the study and to give a sample of blood for HIV test

You may not qualify if:

  • patients in a moribund state,
  • TB meningitis,
  • pre-existing diseases: insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis,
  • pregnancy or breast feeding,
  • psychiatric illness
  • alcoholism
  • contraindication to any medications in the study regimens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Service de Pneumo-phtisiologie de Matiben

Algiers, Algeria

NOT YET RECRUITING

Program Nal. de Control de la Tuberculosis

Santa Cruz, Bolivia

RECRUITING

Centro Internacional de Entrenamiento

Cali, Colombia

RECRUITING

CHU Ignace Deen

Conakry, Guinea

RECRUITING

Health Resesarch Center of Manhica

Manhiça, Mozambique

RECRUITING

Nepal Anti-Tuberculosis Association

Kathmandu, Nepal

ACTIVE NOT RECRUITING

Grupo Levir S.A.

Lima, Peru

RECRUITING

National Institute for Medical Research

Mwanza, Tanzania

ACTIVE NOT RECRUITING

National Hospital of TB and Respiratory Diseases

Hanoi, Vietnam

RECRUITING

Related Publications (1)

  • Lienhardt C, Cook SV, Burgos M, Yorke-Edwards V, Rigouts L, Anyo G, Kim SJ, Jindani A, Enarson DA, Nunn AJ; Study C Trial Group. Efficacy and safety of a 4-drug fixed-dose combination regimen compared with separate drugs for treatment of pulmonary tuberculosis: the Study C randomized controlled trial. JAMA. 2011 Apr 13;305(14):1415-23. doi: 10.1001/jama.2011.436.

    PMID: 21486974DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Christian Lienhardt, MD

    International Union Against Tuberculosis and Lung Diseases

    STUDY DIRECTOR

Central Study Contacts

Sharlette Cook, MPH

CONTACT

+33 1 44 32 06 47scook@iuatld.org

Christian Lienhardt, MD

CONTACT

+ 33 1 44 32 06 43clienhardt@iuatld.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

December 1, 2003

Study Completion

June 1, 2007

Last Updated

September 13, 2006

Record last verified: 2006-09

Locations

CO(1)BO(1)PE(1)VN(1)TA(1)MO(1)AL(1)NE(1)GU(1)