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

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Typhoid fever
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Brief Title

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

Official Title

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

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

clinical clearance

Secondary Outcome

 bacterial clearance

Condition

Typhoid Fever

Intervention

Meropenem Injection

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

126

Start Date

June 20, 2019

Completion Date

December 30, 2020

Primary Completion Date

December 30, 2020

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

Gender

All

Ages

6 Months - 18 Years

Accepts Healthy Volunteers

No

Contacts

farhana zafar, mbbs,fcps, ,

Location Countries

Pakistan

Location Countries

Pakistan

Administrative Informations

NCT ID

NCT04154722

Organization ID

0980419HRPED

Responsible Party

Principal Investigator

Study Sponsor

Ziauddin University

Study Sponsor

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

Verification Date

June 2021