Trials / Completed
CompletedNCT04154722
Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children
Treatment of 21st Century Typhoid Fever in Children;Open Label Mono vs Combination Drug Therapy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 126 (actual)
- Sponsor
- Ziauddin University · Academic / Other
- Sex
- All
- Age
- 6 Months – 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).
Detailed description
Complicated XDR Enteric fever is a very serious systemic disease, caused by an extremely resistant mutant strain of Salmonella Typhi ( the H58 S. Typhi superbug,) that as the name suggests is resistant to not only the first but also the second tier drugs conventionally used for treatment of the same. And as such, warrants immediate antibiotic therapy, but in view of the extended antimicrobial resistance the treatment options are limited to only two effective drugs viz Carbepenem and Azithromycin, as per culture sensitivity. So far, in the absence of universal standardized treatment protocols for XDR complicated typhoid fever in children, random use of either one or both in combination is the current practice. However, keeping antibiotic stewardship in mind, it is imperative to ascertain whether meropenum alone is effective or should be combined with azithromycin in the treatment of this serious disease. Our study therefore compares the efficacy of monotherapy with meropenum or combination with azithromycin based on clinical and microbiologic remission, shortened hospital stay and less chances of relapse in order to then formulate a standardized protocol to treat complicated XDR typhoid in children thus preventing yet further antimicrobial resistance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Meropenem Injection | inj meropenum for 10 days |
| DRUG | Azithromycin Powder | syp azithromycin for10days |
Timeline
- Start date
- 2019-06-20
- Primary completion
- 2020-12-30
- Completion
- 2020-12-30
- First posted
- 2019-11-06
- Last updated
- 2021-06-16
Locations
1 site across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT04154722. Inclusion in this directory is not an endorsement.