Health Condition 1: J158- Pneumonia due to other specified bacteria
Conditions
Interventions
Intervention1: Chloroquine based HREZ combination regimens: Route of Administration: Oral
Dosage range: 50,100,200 & 300 mg/day (Chloroquine)and Standard HREZ regimen for TB,
Frequency: Once daily
Dur
Sponsors
Foundation for Neglected Disease Research
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adult male and female subjects aged 18 years and above with body weight between 30-65 kg. 2) Individuals who are newly diagnosed with pulmonary tuberculosis through GeneXpert test. Individuals must be previously untreated and test positive for sputum GeneXpert. 3) Subjects must be susceptible to rifampicin as detected by a cartridge-based nucleic acid amplification test. 4) Willingness to undergo HIV testing. 5) Subjects must have never been treated with multidrug anti tuberculosis therapy for more than a week. 6) Willingness to attend the treatment center for supervised treatment and remain within the study area limit. 7) Willingness to give blood samples for PK analysis on day 1 and day 14. 8) Willingness to sign the informed consent form and adhere to study procedures and follow-up. 9) Willingness to join the Directly Observed Treatment, Short-Course (DOTS) program 10) Consent to home visits.
Exclusion criteria
Exclusion criteria: 1) Female subjects who are pregnant, breastfeeding, or planning to conceive during the study. 2) Subjects with extra-pulmonary tuberculosis or drug-resistant tuberculosis (single drug resistance, H, or R). 3) Subjects with a body weight less than 30 kg or greater than 65 kg. 4) Subjects with a prior history of exposure to anti-tuberculosis treatment for more than a week. 5) Subjects with a history of liver disease or current Alanine aminotransferase levels greater than three times the upper limit of normal or total bilirubin concentration exceeding the upper limit of normal. 6) Subjects who test positive for hepatitis B virus surface antigen, hepatitis C virus antibody, and HIV. 7) Subjects with concomitant psychiatric illness or a history of seizures. 8) Anybody testing positive for malaria in the last two months prior to enrolment in the study. 9) Diagnosed cases of extrapulmonary tuberculosis. 10) Subjects who tested positive for COVID-19 with lung involvement. 11) Subjects receiving treatment for rheumatoid arthritis (RA)/autoimmune disorders and CQ/hydroxy-CQ therapy. 12) Subjects with malaria and Q-fever undergoing CQ/hydroxy-CQ therapy or have taken CQ/ hydroxy-CQ therapy 2 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Safety and tolerability of CQ. The assessment includes monitoring clinical manifestations and laboratory abnormalities in the blood. b) Overall tolerability of the CQ-based combination regimens will be evaluated by assessing treatment emergent adverse events.Timepoint: Day 0, Day 1, Day 14 & Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Pharmacokinetics (PK) Assessment: Establishment of the PK profile of the CQ-based HREZ combination regimen. b) Safe Dose Determination: Determination of safe CQ dose for the development of a combination regimen. c) Sputum Culture Conversion Evaluation: Determination of sputum culture conversion rates of CQ-based HREZ combination regimen compared to HREZ treatment alone by inoculating samples into MGIT and demonstrating the time to culture positivity (TTP)Timepoint: Day 0, Day 1, Day 14 & Day 180 | — |
Countries
India
Contacts
Public ContactMeena Dalal
Hassan Institute of Medical Sciences
Outcome results
None listed