A Pragmatic Trial With Optimized Dose of Rifampicin and Moxifloxacin for the Treatment of Drug Susceptible Pulmonary Tuberculosis

Launched by STELLAH MPAGAMA · Oct 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for drug-susceptible pulmonary tuberculosis (TB) using a combination of rifampicin and moxifloxacin. The goal is to see if a shorter, four-month treatment regimen is just as effective as the standard longer treatment, especially for patients in Africa who may also be living with HIV. With TB being a significant health issue globally, especially during the recent pandemic, this study aims to explore innovative ways to improve TB treatment and control.

To be eligible for the trial, participants must be at least 18 years old, weigh at least 35 kg, and have a confirmed diagnosis of pulmonary TB without rifampicin resistance. Other important requirements include giving informed consent, having a valid residence, and being able to commit to the study. Participants can expect regular check-ups and monitoring throughout the treatment process. It’s essential for potential participants to be aware that those with certain health conditions or recent treatments may not qualify for the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Each patient must meet all the following inclusion criteria prior to enrolment into the trial:
• • 1. The patient has given fully informed, signed written or witnessed oral informed consent for study participation prior to all trial-related procedures, including HIV testing if HIV status is not known.
• • 2. The patient has a diagnosis of pulmonary TB established by Xpert MTB/RIF® result which confirms "low" "medium" or "high" level detection of M tuberculosis and does not detect rifampicin resistance.
• • 1. If the patient has been referred from a clinic at which the pre-screening clinical diagnostic test for TB was an Xpert MTB/RIF® assay done at the trial laboratory, and the full read-out of that result is available, the test does not need to repeated to confirm eligibility.
• • 2. If the patient has been referred from a clinic at which the pre-screening clinical diagnostic test for TB was an Xpert MTB/RIF® assay done at a non-trial laboratory, but the full read-out of that result is available, the test does not need to repeated to confirm eligibility.
• • 3. If the patient has been referred to the study from a clinic from which the full pre-screening clinical diagnostic Xpert MTB/RIF® test result is unavailable, a repeat Xpert MTB/RIF® assay should be performed by the study laboratory to confirm eligibility before recruitment.
• • 3. The patient should be aged ≥ 18 years on the day of providing informed consent.
• • 4. The patient has a body weight in light clothing and without shoes of at least 35kg.
• • 5. Female patients of child-bearing potential must have a negative urine or serum pregnancy test ≤ 7 days prior to screening, and consent to practice an effective method of contraception until completion of therapy.
• • 6. The patient must have a verifiable residence location and telephone number that is accessible if necessary for contact during follow-up.
• Exclusion Criteria:
• * Patients for whom one of the following criteria is met will be excluded from the trial:
• • 1. There is concern about any circumstances that raise concern about free, informed consent to study participation.
• • 2. The patient's pre-screening or screening Xpert MTB/RIF® assay result is "negative","trace", or "very low" positive.
• • 3. At least one M tuberculosis isolate, either cultured or detected through molecular assays from sputum obtained from the patient prior to treatment initiation is found to be resistant to one or more of: rifampicin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones (late exclusion).
• • 4. The patient is in poor general condition where delay in treatment cannot be tolerated, or death within three months is likely, as assessed by the investigator.
• • 5. The patient had a nose/throat swab which was positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2), on Polymerase Chain Reaction (PCR) or a rapid diagnostic test ≤ 14 days preceding study recruitment.
• • 6. The patient is pregnant or breast-feeding (female patients only).
• • 7. The patient is unable to take oral medications.
• • 8. The patient has received any investigational drug in the past three months.
• • 9. The patient has received more than five days of treatment directed against active tuberculosis ≤ 6 months preceding initiation of study drugs.
• • 10. The patient has known intolerance to any of the study drugs, or conditions for which they are contra-indicated.
• • 11. The patient is unwilling, or unable to adhere to requirements regarding restricted use of other medications during the study. Restricted medications will include medications which prolong the QTc interval, and CYP450 inhibitors or inducers.
• • 12. The patient is due to initiate, or requires continuation of, non-efavirenz, non-dolutegravir-based anti-retroviral therapy for HIV infection.
• • 13. The patient has decompensated liver disease and/or aminotransaminases \>3x upper limit of normal (ULN), serum total bilirubin level \>1.5x ULN or serum/plasma creatinine level \>x2 ULN.
• • 14. The patient has a baseline QTc interval of \>450ms.
• • 15. The patient is being, or about to be, treated for malaria.
• • 16. The patient has other medical conditions that, in the investigator's judgement, make study participation not in the individual's best interest.