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

Typhoid Fever Clinical Trial

— [XDRTYPHOID]  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154722
• Other study ID #: 0980419HRPED
• Status: Completed
• Phase: Phase 4
• Start date: June 20, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2021
• Source: Ziauddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Typhoid Fever

Intervention

Drug:
• Meropenem Injection
inj meropenum for 10 days
• Azithromycin Powder
syp azithromycin for10days

Locations

Country	Name	City	State
Pakistan	Ziauddin University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	relapse of typhoid fever	reappearance of the signs and symptoms of typhoid fever along with positive blood cultures	15 days after completing treatment
Primary	clinical clearance	improvement of the signs and symptoms as given in the operational definition	10 days
Secondary	bacterial clearance	negative blood cultures	5 days