Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT00651066
Eligibility Criteria:
Inclusion Criteria:
* Pulmonary tuberculosis defined as either
* at least 2 sputum smears positive for AFB
* 1 sputum smear positive for AFB and a chest radiograph compatible with active tuberculosis
* 1 sputum culture positive and and a chest radiograph compatible with active tuberculosis
* a clinical history and chest radiograph compatible with active tuberculosis and 2 sputum smear negative for AFB
* Positive HIV antibody and CD4 count \<=250 /mm3
* Weight \> 40 kg
* No history of ART
* No grade 3 or 4 clinical or laboratory findings
* Negative pregnancy test and appropriate contraceptive measures during the duration of the trial for female of childbearing age
* Having a firm home address that is readily accessible
* Karnofsky score\>=80%
Exclusion Criteria:
* History of TB or MDR TB treatment
* Concomitant OI requiring additional anti-infectious treatment
* Formal contraindication to any drug used in the trial
* Diabetes mellitus requiring drug treatment
* Recreational drug or alcohol abuse
* History of drug hypersensitivity to TB or related medications
* Interrupted TB therapy for more than 1 week
* Less than 90% adherent to first 6 weeks of intensive phase chemotherapy
* Mental illness that could impair ability to give informed consent or result in poor adherence to trial protocol and therapy
* Neutropenia \<1200 /L, anaemia \<6.8 g/dL, liver function test \> grade 2
* Requiring concomitant medications that may potentially interact with study drugs
* Pregnant or lactating women
* Karnofsky score \>80%
* Any condition rendering the patient unable to understand the nature, scope, and possible consequences of thes study and to provide consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00651066
Study Brief:
Protocol Section:
NCT00651066