The effectiveness of azithromycin alone and azithromycin plus cefixime for the treatment of typhoid fever in South Asia has been studied.
- Conditions
- Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/10/037047
- Lead Sponsor
- The University of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. A history of fever at presentation for 72 hours or more and a documented fever (37.5 degrees Celsius or more(axillary) or 38degree Celsius or more(oral))
2. Age 2 years or more (and weight 10kg and more) to 65 years
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 or more
5. Able to take oral treatment
6. Able to attend for follow-up and can be contacted by telephone
7. 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, hemodynamic 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 five 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 antidepressants, or anticonvulsants) that may also cause prolonged QT interval
13. PCR positive for Co-Vid 19 before or after randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical failure and Microbiological failureTimepoint: 28 days
- Secondary Outcome Measures
Name Time Method Clearance of faecal carriageTimepoint: One and three month follow-up visit;cost-effectiveness of the treatment inTimepoint: Initiation of treatment and one month follow-up visit;Fever clearance timeTimepoint: Under observation following the initiation of treatment;Occurrence of adverse events in each treatment armTimepoint: Under observation following the initiation of treatment;Time to treatment failureTimepoint: Under observation following the initiation of treatment