PACTR202407655325739
Not yet recruiting
Phase 3
Confirmatory Trial of Adjunctive N-acetylcysteine to Prevent and/or Treat Post Tuberculosis Lung Disease (NAC-PTLD)
ConditionsTuberculosis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Tuberculosis
- Sponsor
- The Aurum Institute
- Enrollment
- 484
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Persons aged 18 to 65 years
- •2\. Willing and able to provide signed written consent or witnessed oral consent with thumbprint
- •in the case of illiteracy, prior to undertaking any trial\-related procedures.
- •3\. Body weight (in light clothing without shoes) between 30 and 90 kg.
- •4\. Xpert TB/RIF OR Ultra showing RIF\-S\-MTB, with subsequent confirmation of MTB by culture.
- •5\. Chest radiograph meeting criteria for moderate or far advanced pulmonary tuberculosis 1
- •6\. FEV1 \=65% of predicted based on age, height, sex, and race
- •7\. If female, of child\-bearing potential and sexually active, willing to use an effective contraceptive
- •method for the duration of study participation
- •8\. HIV\-1/2 seronegative, OR if seropositive, CD4 T cell count \=100/µl AND willing to either continue
Exclusion Criteria
- •1\. Any condition for which participation in the trial, as judged by the investigator, could compromise
- •the well\-being of the subject or prevent, limit or confound protocol specified assessments,
- •such as pneumothorax or clinically significant pleural effusion.
- •2\. Current or imminent (within 24 hr) treatment for malaria.
- •3\. Pregnancy or breastfeeding
- •4\. Is critically ill, and in the judgment of the investigator has a diagnosis likely to result in death
- •during the trial or the follow\-up period.
- •5\. TB meningitis or other forms of severe tuberculosis with high risk of a poor outcome as judged
- •by the investigator.
- •6\. History of allergy or hypersensitivity to any of the trial therapies or related substances, including
Outcomes
Primary Outcomes
Not specified
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