Comparison of four Fixed Dose Combinations versus standard treatment with separate anti-TB drugs for treatment of pulmonary tuberculosis

Not Applicable

Completed

• Conditions: Tuberculosis; Infections and Infestations

• Registration Number: ISRCTN95204603
• Lead Sponsor: DP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-26
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Patients with newly diagnosed pulmonary tuberculosis (with or without pleural effusion) will be admitted to the study provided they fulfill the following criteria:
1. Two sputum specimens positive for tubercle bacilli on direct smear microscopy. A patient is considered smear positive if:
1.1. 2 out of 3 consecutive sputum smears are read as positive, or
1.2. 2 out of 5 are read as positive in the event that only one of the first three smear is positive, in which case the patient will be asked for two more specimens: one morning and one spot.
2. No history of previous anti-tuberculosis chemotherapy, or antiretroviral therapy
3. Aged 18 years and over
4. A firm home address and intent to remain there during the entire treatment and follow up period
5. Informed consent to participate in the study
6. Weight between 40.00 kg and 70.00 kg inclusive
7. Acceptance of human immunodeficiency virus (HIV) counselling and testing
8. CD4 more than or equal to 220 cells/microlitre blood if the patient is HIV positive in Nigeria
9. CD4 > 350cells/microlitre blood if the patient is HIV positive In Ethiopia

Exclusion Criteria

1. Positive urinary pregnancy test or obviously pregnant on physical examination
2. Additional extrapulmonary TB (e.g. bone, meningeal, peritoneal or miliary)
3. Contraindications to any medications in the study regimens (e.g. documented allergy, optic neuritis, blurred vision, red-green colour blindness and poor visual acuity any active hepatic diseases
4. Evidence (laboratory and/or clinical history) of pre-existing non-tuberculous disease likely to affect the response to, or assessment of, treatment:
4.1. Diabetes mellitus
4.2. Liver impairment
4.3. Renal impairment
4.4. Peripheral neuropathy
4.5. Terminal illness such as malignancy
5. Requirement for hospitalisation for any reason other than directly observed treatment (DOT)
6. Concomitant immunosuppressive treatment during the whole study period
7. Psychiatric illness, alcohol or drug abuse likely to lead to uncooperative behaviour
8. Patients on antiretroviral treatment during TB treatment period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rates at end of treatment (6 months)