The azithromycin and cefixime treatment of typhoid in South Asia trial
- Conditions
- The out-patient treatment of clinically suspected or confirmed uncomplicated typhoid fever in South AsiaInfections and Infestations
- Registration Number
- ISRCTN18065452
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35097222/ (added 03/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1500
1. A history of fever at presentation for >48 hours and a documented fever(=37.5oC (axillary))
2. Aged =2 years (and =10 kg) to 65 years old
3. No clear focus of infection on initial clinical evaluation
4. Malaria RDT negative; dengue NS1 RDT negative; scrub typhus RDT negative; CRP rapid test =10 mg/L. Able to take oral treatment ( Exception case if any Of RDT is positive or CRP< 10, but blood/stool culture positive case).
5. Able to attend for follow-up and can be contacted by telephone
6. Written fully informed consent to participate in the study including assent for children in addition to parental/legal guardian consent
1. History of fever for >14 days
2. Pregnant or positive pregnancy test or breast-feeding
3. Presence of clinical symptoms or signs indicating a focal infection such as pneumonia; urinary infection, meningitis, eschar
4. Obtundation, haemodynamic shock, visible jaundice, gastrointestinal bleeding or any signs of severe disease that may require immediate hospitalization
5. Being treated for TB or HIV or severe acute malnutrition
6. Patients with cardiac disease
7. Patient requiring intravenous antibiotics for any reason
8. Previous history of hypersensitivity to any of the treatment options
9. Either of the trial drugs are contraindicated for any reason (e.g. drug interactions)
10. Has received azithromycin or cefixime in the last 5 days
11. Receiving another antimicrobial and responding clinically to the treatment as judged by the attending clinician.
12. Being on another drug (for example certain kinds of anti-depressants, or anticonvulsants) that may also cause prolonged QT interval
13. COVID-19 PCR/antigen positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> A composite outcome of treatment failure by the 28th day after the initiation of treatment will be defined by either of the following events:<br> 1. Clinical failure: Persistence of fever on day 7 (168 h) post-treatment initiation or the need for rescue treatment as judged by the Trial Clinician or the development of any complication (e.g., clinically significant bleeding, fall in the Glasgow Coma Scale score, perforation of the gastrointestinal tract) or Syndromic enteric fever relapse within 28 days of initiation of treatment<br> 2. Microbiological failure: A positive blood culture for S. Typhi or S. Paratyphi on day 7 of treatment regardless of the presence of fever (microbiological failure) or blood culture-confirmed typhoid fever relapse within 28 days of initiation of treatment<br>
- Secondary Outcome Measures
Name Time Method