A two-arm single-blind randomised comparison of four Fixed Dose Combinations versus standard treatment with separate anti-TB drugs for treatment of pulmonary tuberculosis

DP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR)0 sites1,000 target enrollmentJanuary 26, 2012

Overview

Phase: 未知
Intervention: Not specified
Conditions: Tuberculosis
Sponsor: DP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR)
Enrollment: 1000
Status: Completed
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

January 26, 2012

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Sponsor

DP/World Bank/WHO Special Programme for Research & Training in Tropical Diseases (TDR)

•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

•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)