Ziauddin University
Karachi, Sindh, 75600, Pakistan
NCT Number: NCT04154722
This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).
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Notify Me6 month–18 year
All sexes
Interventional
Phase 4
Karachi, Sindh, 75600, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with extended drug resistant typhoid fever defined as culture proven typhoid fever caused by Salmonella Typhi or Para typhi resistant to Ampicillin, Chloramphenicol,Co trimoxazole,Quinolones and Ceftriaxone along with two or more of the following condition
Exclusion criteria
inj meropenum for 10 days
Other names: meroneum, penro
syp azithromycin for10days
Other names: azomax, zetro
Time frame: 10 days
improvement of the signs and symptoms as given in the operational definition
Time frame: 5 days
negative blood cultures
Time frame: 15 days after completing treatment
reappearance of the signs and symptoms of typhoid fever along with positive blood cultures
Ziauddin University
Other
Treatment of 21st Century Typhoid Fever in Children;Open Label Mono vs Combination Drug Therapy
Acronym: [XDRTYPHOID]
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