Accuracy and Consequences of Using Trial-of-antibiotics for TB Diagnosis (ACT-TB Study)

• Status: Completed
• Trial end date: 2020-04-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborator: University of Malawi College of Medicine
• Treatments: Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Azithromycin

Criteria

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