Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis

Launched by FUNDACIÓ INSTITUT GERMANS TRIAS I PUJOL · Sep 29, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of two common medications, acetylsalicylic acid (often known as aspirin) and ibuprofen, as additional treatments for patients with tuberculosis (TB). The goal is to see if these medications can help improve the effectiveness of the standard TB treatment recommended by the World Health Organization, particularly in patients with drug-sensitive and multi-drug resistant TB. The trial is currently looking for participants aged between 18 and 60 who have a confirmed diagnosis of pulmonary TB.

To take part in the study, participants must provide written consent and be willing to undergo certain tests, including a pregnancy test for women who could become pregnant. It’s important to know that individuals with certain health conditions or who are currently receiving specific treatments for TB may not be eligible. Participants in the trial will be monitored closely and can expect to receive standard TB care along with the study medications to help researchers determine how well they work together. This trial aims to find better ways to treat TB, which can be a serious illness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults, 18- 60 years of age
• • 2. Written informed consent in a language they understand. This includes informed consent to be in the trial and informed consent to collect specimens.
• • 3. Laboratory confirmed pulmonary TB (with or without extrapulmonary involvement) defined as a hard copy of a sputum laboratory result that reports M. tuberculosis (Mtb) detection by a WHO-recommended assay -both rapid molecular assays or mycobacterial culture with subsequent speciation are acceptable as inclusion criteria.
• • 4. Women of childbearing potential (including females \<2 years post-menopausal) must have a negative pregnancy test at enrolment.
• • 5. Participants must be willing to have an HIV test done unless there is compelling evidence that the patient is HIV-infected at the time of randomization.
• Exclusion Criteria:
• • 1. Has a comorbid condition where treatment with aspirin, ibuprofen or other NSAID is indicated (e.g. cardiovascular disease, rheumatic fever, chronic pain, etc.)
• • 2. People institutionalized (incarceration in jail or prison, or due to chronic mental illness). If incarcerated during the study, participants may be terminated, those incarcerated in the first 8 weeks of follow up will be late exclusions and replaced\*. Patients either who are planned to be hospitalized or currently hospitalized whilst treated for MDR TB in a TB hospital or ward may be enrolled.
• • 3. Receipt of multi-drug TB treatment (including rifamycin plus isoniazid preventive treatment regimens) for ≥3 days in the 6 months prior to randomization. Participants who have received ≥3 days of TB preventive treatment in the month prior to TB treatment initiation will also be excluded.
• • 4. Currently Pregnancy/breastfeeding. Women who conceive and are found to be pregnant in the first 4 weeks of the trial will be terminated from the trial and excluded from the analysis.
• 5. Any of the following laboratory parameters taken prior to randomization:
• • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN);
• • Total bilirubin \> 2 x ULN;
• • Neutrophil count ≤ 700 neutrophils /mm3;
• • Platelet count \< 50,000 cells / mm3
• • Haemoglobin concentration less than 8 g/dL
• • Serum creatinine concentration more than twice the upper limit of normal
• 6. Co-treatment in the three months prior to randomization, or planned treatment over the course of the trial follow up with any one of the following agents:
• • anticoagulant therapy
• • immune modulating therapy (cancer treatments, any oral or daily use of inhaled steroids;
• • Antacids or proton pump inhibitors - including self-treatment and prescription
• • 7. History or clinical record of sensitivity, asthma or allergy that could be attributed to NSAIDs
• • 8. Weight \< 45kg at baseline.
• 9. History or clinical record suggestive of any of the following in the past two years:
• • peptic ulcer disease or gastro-intestinal bleeding,
• • coagulopathy or other bleeding disorder,
• • renal disease requiring hospitalization - in addition, any prior record at any time of acute kidney injury will be an exclusion criterion.
• • liver disease requiring further investigation or hospitalization,
• • underlying cardiovascular disease or risk factors for cardiovascular disease.
• 10. Patients with HIV infection (irrespective of ART status) if:
• • CD4 \<350 cells/mm3
• • if on ART, unsuppressed (\>200 copies/ml) viral load
• • if not on ART, either in the opinion of the attending doctor or according to local ART guidelines, the patient should initiate ART during the 8-week initial placebo or NSAID treatment phase.
• • 11. Alcohol use: potential participant either self-reports or in the investigator's opinion that the patient drinks more than an average of four units/day over a usual week or is a binge drinker (men: 5 or more drinks; women: consume 4 or more drinks, in about 2 hours).
• • 12. Major co-morbid conditions or any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results.