The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial)

Launched by OXFORD UNIVERSITY CLINICAL RESEARCH UNIT, VIETNAM · Apr 14, 2020

Keywords

ClinConnect Summary

The ACT-South Asia Trial is studying the effectiveness of a combination treatment using two antibiotics, azithromycin and cefixime, for patients with typhoid fever. Typhoid fever is a serious illness that affects millions of people, particularly in South Asia, and can lead to severe health issues and financial strain on families. This trial aims to find out if using both antibiotics together can help patients recover faster than using just one antibiotic on its own. The study will involve about 1,500 participants from Bangladesh, India, Nepal, and Pakistan, and will compare the outcomes after one week and follow-ups at one and three months.

To be eligible for this trial, participants should be between 2 and 65 years old, have had a fever for at least three days, and have no clear signs of another infection. They should also be able to take oral medications and attend follow-up appointments. The study will ensure that neither the participants nor the researchers know who is receiving which treatment, helping to keep the results unbiased. If the combination treatment proves to be more effective, it could be a significant advancement for treating typhoid fever in affected regions. Participants will also help researchers understand the financial impact of the illness on families and healthcare systems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A history of fever at presentation for ≥ 72 hours and a documented fever (≥37.5oC (axillary) or ≥38oC (oral))
• • Age ≥ 2 years (and ≥ 10kg) to 65 years
• • No clear focus of infection on initial clinical evaluation
• • Malaria rapid Diagnostic test( RDT) negative; dengue nonstructural protein(NS) 1 RDT negative; scrub typhus RDT negative; c-reactive protein(CRP) rapid test ≥10 mg/L
• • Able to take oral treatment
• • Able to attend for follow-up and can be contacted by telephone
• • Written fully informed consent to participate in the study including assent for children in addition to parental/legal guardian consent.
• Exclusion Criteria:
• • History of fever for \>14 days
• • Pregnant or positive pregnancy test or breast-feeding
• • Presence of clinical symptoms or signs indicating a focal infection such as pneumonia; urinary infection, meningitis, eschar
• • Obtundation, haemodynamic shock, visible jaundice, gastrointestinal bleeding or any signs of severe disease that may require immediate hospitalisation
• • Being treated for TB or HIV or severe acute malnutrition
• • Patients with cardiac disease
• • Patient requiring intravenous antibiotics for any reason
• • Previous history of hypersensitivity to any of the treatment options
• • Either of the trial drugs are contraindicated for any reason (e.g. drug interactions)
• • Has received azithromycin or cefixime in the last five days
• • Receiving another antimicrobial and responding clinically to the treatment as judged by the attending clinician.