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

NCT03545373 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1583

Last updated 2021-04-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Azithromycin

Azithromycin tablet taken orally

DRUG

Amoxicillin

Amoxicillin tablets taken orally

Sponsors & Collaborators

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Titus H Divala, MBBS MPH MS · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2020-03-14
Completion
2020-04-14

Countries

  • Malawi

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03545373 on ClinicalTrials.gov