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Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children ([XDRTYPHOID])

Primary Purpose

Typhoid Fever

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Meropenem Injection
Azithromycin Powder
Sponsored by
Ziauddin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Typhoid Fever focused on measuring XDR TYPHOID FEVER

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziauddin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

meropenum and azithromycin group

meropenum group

Arm Description

inj meropenum 20mg/kg/dose I/v in 3 divided doses and syp azithromycin 20mg/kg/day in 2 divided doses.

inj meropenum 20mg/kg/dose I/v in 3 divided doses

Outcomes

Primary Outcome Measures

clinical clearance
improvement of the signs and symptoms as given in the operational definition

Secondary Outcome Measures

bacterial clearance
negative blood cultures

Full Information

First Posted
November 4, 2019
Last Updated
June 15, 2021
Sponsor
Ziauddin University
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1. Study Identification

Unique Protocol Identification Number
NCT04154722
Brief Title
Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children
Acronym
[XDRTYPHOID]
Official Title
Treatment of 21st Century Typhoid Fever in Children;Open Label Mono vs Combination Drug Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typhoid Fever
Keywords
XDR TYPHOID FEVER

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
meropenum and azithromycin group
Arm Type
Experimental
Arm Description
inj meropenum 20mg/kg/dose I/v in 3 divided doses and syp azithromycin 20mg/kg/day in 2 divided doses.
Arm Title
meropenum group
Arm Type
Active Comparator
Arm Description
inj meropenum 20mg/kg/dose I/v in 3 divided doses
Intervention Type
Drug
Intervention Name(s)
Meropenem Injection
Other Intervention Name(s)
meroneum, penro
Intervention Description
inj meropenum for 10 days
Intervention Type
Drug
Intervention Name(s)
Azithromycin Powder
Other Intervention Name(s)
azomax, zetro
Intervention Description
syp azithromycin for10days
Primary Outcome Measure Information:
Title
clinical clearance
Description
improvement of the signs and symptoms as given in the operational definition
Time Frame
10 days
Secondary Outcome Measure Information:
Title
bacterial clearance
Description
negative blood cultures
Time Frame
5 days
Other Pre-specified Outcome Measures:
Title
relapse of typhoid fever
Description
reappearance of the signs and symptoms of typhoid fever along with positive blood cultures
Time Frame
15 days after completing treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
farhana zafar, mbbs,fcps
Organizational Affiliation
ziauddin university north campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziauddin University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75600
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children

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