- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04154722
Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children ([XDRTYPHOID])
Treatment of 21st Century Typhoid Fever in Children;Open Label Mono vs Combination Drug Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Sindh
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Karachi, Sindh, Pakistan, 75600
- Ziauddin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- High grade fever spikes for more than three days
- Refusal to eat or drink
- Drowsy or Unconscious
- Convulsions
- Dehydration due to diarrhea or vomiting
- Abdominal distension with or without tenderness
- Bleeding diathesis like petechial rash, gum bleed, melena
- Jaundice or alanine transaminase more than twice of the normal range
- Thrombocytopenia less than fifty thousand
- Increase Prothrombin time and activated partial thromboplastin time
- Electrolyte imbalance like hyponatremia, hypernatremia, hypokalemia, hyperkalemia, metabolic acidosis
- Hypoglycemia
- Signs of shock like cold and mottled skin, feeble pulses, tachycardia, decreased blood pressure
Exclusion Criteria:
- Not given informed consent
- Children who need ventilator or two inotrope support
- Severe malnutrition/immunocompromised patient
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: meropenum and azithromycin group
inj meropenum 20mg/kg/dose I/v in 3 divided doses and syp azithromycin 20mg/kg/day in 2 divided doses.
|
inj meropenum for 10 days
Other Names:
syp azithromycin for10days
Other Names:
|
Active Comparator: meropenum group
inj meropenum 20mg/kg/dose I/v in 3 divided doses
|
inj meropenum for 10 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical clearance
Time Frame: 10 days
|
improvement of the signs and symptoms as given in the operational definition
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bacterial clearance
Time Frame: 5 days
|
negative blood cultures
|
5 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relapse of typhoid fever
Time Frame: 15 days after completing treatment
|
reappearance of the signs and symptoms of typhoid fever along with positive blood cultures
|
15 days after completing treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: farhana zafar, mbbs,fcps, ziauddin university north campus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0980419HRPED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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