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
1 other identifier
interventional
126
1 country
1
Brief Summary
This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2019
CompletedFirst Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJune 16, 2021
June 1, 2021
1.5 years
November 4, 2019
June 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical clearance
improvement of the signs and symptoms as given in the operational definition
10 days
Secondary Outcomes (1)
bacterial clearance
5 days
Other Outcomes (1)
relapse of typhoid fever
15 days after completing treatment
Study Arms (2)
meropenum and azithromycin group
EXPERIMENTALinj meropenum 20mg/kg/dose I/v in 3 divided doses and syp azithromycin 20mg/kg/day in 2 divided doses.
meropenum group
ACTIVE COMPARATORinj meropenum 20mg/kg/dose I/v in 3 divided doses
Interventions
inj meropenum for 10 days
syp azithromycin for10days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Not given informed consent
- Children who need ventilator or two inotrope support
- Severe malnutrition/immunocompromised patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ziauddin University
Karachi, Sindh, 75600, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
farhana zafar, mbbs,fcps
ziauddin university north campus
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD resident
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 6, 2019
Study Start
June 20, 2019
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
June 16, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share