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