Accuracy and Consequences of Using Trial-of-antibiotics for TB Diagnosis (ACT-TB Study) (NCT03545373) | Clinical Trial Compass
CompletedPhase 3
Accuracy and Consequences of Using Trial-of-antibiotics for TB Diagnosis (ACT-TB Study)
Malawi1,583 participantsStarted 2019-02-25
Plain-language summary
This is a three-arm, open-label individually randomised controlled clinical trial investigating the benefits of the diagnostic use of broad-spectrum antimicrobials during the diagnostic process for tuberculosis (TB) and the risk of antimicrobial resistance. Adults (≥18 years) presenting to primary care with TB symptoms will, after excluding acute illness, be randomised (1:1:1) to receiving azithromycin, amoxicillin or standard care. Diagnostic accuracy will be ascertained by comparing self-reported response to treatment on Day-8 to results of mycobacteriology tests (MTB culture, smear microscopy and Xpert/MTB/RIF). Antimicrobial resistance will be ascertained by comparing arms with respect to incidence of resistant Streptococcus pneumonia carriage cultured from nasopharyngeal swabs collected on Day-28. Clinical benefit will be ascertained by comparing clinical outcomes by Day-29.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ambulatory clinic attendees presenting with cough
* Unwell for at least 14 days
* Aged at least 18 years
* Reside in Blantyre and willing to return to the same clinic for follow up visits over the entire study period.
Exclusion Criteria:
* Self-reported allergy to study medications
* WHO/Malawi National tuberculosis Program (NTP) danger signs: respiratory rate \> 30/min, temperature \>39oC, Heart rate \>120/minute, confused/agitated, respiratory distress, systolic blood pressure \<90 mmHg, inability to walk unassisted
* Treated with antibiotics other than co-trimoxazole prophylaxis within the past 14 days
* Tuberculosis treatment or isoniazid preventive therapy within the last 6 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy of trial-of-antibiotics: proportion of patients without tuberculosis (by sputum tests) who report improvement of their baseline illness when asked 7 days after randomisation (Day 8 study visit).
Timeframe: Day 1 to Day 8
2
Clinical impact of trial-of-antibiotics
Timeframe: Day 1 to Day 29
Trial details
NCT IDNCT03545373
SponsorLondon School of Hygiene and Tropical Medicine