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

NCT ID: NCT04154722

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2020-12-30

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.

Conditions

Typhoid Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Meropenem Injection

Intervention Type: DRUG

inj meropenum for 10 days

Azithromycin Powder

Intervention Type: DRUG

syp azithromycin for10days

meropenum group

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

Group Type: ACTIVE_COMPARATOR

Meropenem Injection

Intervention Type: DRUG

inj meropenum for 10 days

Interventions

Meropenem Injection

inj meropenum for 10 days

Intervention Type: DRUG

Azithromycin Powder

syp azithromycin for10days

Intervention Type: DRUG

Other Intervention Names

meroneum; penro; azomax; zetro

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziauddin University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Fatima G Siddiqi

MD resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

farhana zafar, mbbs,fcps

Role: PRINCIPAL_INVESTIGATOR

ziauddin university north campus

Locations

Ziauddin University

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

0980419HRPED

Identifier Type: -

Identifier Source: org_study_id