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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154722
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Fatima G Siddiqi, Ziauddin University

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).

Condition or disease Intervention/treatment Phase
Typhoid Fever Drug: Meropenem Injection Drug: Azithromycin Powder Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of 21st Century Typhoid Fever in Children;Open Label Mono vs Combination Drug Therapy
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020


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.
Drug: Meropenem Injection
inj meropenum for 10 days
Other Names:
  • meroneum
  • penro

Drug: Azithromycin Powder
syp azithromycin for10days
Other Names:
  • azomax
  • zetro

Active Comparator: meropenum group
inj meropenum 20mg/kg/dose I/v in 3 divided doses
Drug: Meropenem Injection
inj meropenum for 10 days
Other Names:
  • meroneum
  • penro




Primary Outcome Measures :
  1. clinical clearance [ Time Frame: 10 days ]
    improvement of the signs and symptoms as given in the operational definition


Secondary Outcome Measures :
  1. bacterial clearance [ Time Frame: 5 days ]
    negative blood cultures


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154722


Contacts
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Contact: fatima g siddiqi, mbbs,mcps 9+922132851880 ext 3218 fatimagsiddiqi@yahoo.com
Contact: heena s rais, mbbs,fcps 9+922132851880 ext 3219 heena.rais@zu.edu.pk

Locations
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Pakistan
Ziauddin University Recruiting
Karachi, Sindh, Pakistan, 75600
Sponsors and Collaborators
Ziauddin University
Investigators
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Principal Investigator: farhana zafar, mbbs,fcps ziauddin university north campus
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Responsible Party: Dr. Fatima G Siddiqi, MD resident, Ziauddin University
ClinicalTrials.gov Identifier: NCT04154722    
Other Study ID Numbers: 0980419HRPED
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Fatima G Siddiqi, Ziauddin University:
XDR TYPHOID FEVER
Additional relevant MeSH terms:
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Typhoid Fever
Fever
Body Temperature Changes
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Azithromycin
Meropenem
Anti-Bacterial Agents
Anti-Infective Agents