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

June 15, 2021 updated by: Dr. Fatima G Siddiqi, Ziauddin University

Treatment of 21st Century Typhoid Fever in Children;Open Label Mono vs Combination Drug Therapy

This study evaluates whether XDR Typhoid fever in children can be effectively treated with monotherapy (meropenum alone), or a combination (meropenum and azithromycin).

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sindh
      • Karachi, Sindh, Pakistan, 75600
        • Ziauddin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • meroneum
  • penro
syp azithromycin for10days
Other Names:
  • azomax
  • zetro
Active Comparator: meropenum group
inj meropenum 20mg/kg/dose I/v in 3 divided doses
inj meropenum for 10 days
Other Names:
  • meroneum
  • penro

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: farhana zafar, mbbs,fcps, ziauddin university north campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2019

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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