Efficacy of Levofloxacin Versus Ciprofloxacin in the Treatment of Childhood Typhoid Fever

NCT07150065 — Phase 2, Completed, 360 participants, Avicenna Medical College Lahore

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07150065
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	360 (Actual)
Sponsor	Avicenna Medical College Lahore (Other)
Conditions	Typhoid, Fever
Interventions	Levofloxacin, ciprofloxacin (Drug)
Dates	start 2025-02-07, primary completion 2025-08-07, completion 2025-08-07, first posted 2025-09-02, last updated 2025-09-02
Locations	1 site in Pakistan

-Summary

Sample size of 360 children with typhoid fever were enrolled and randomly divided in two groups. All the children were enrolled in the trial from Pediatrics emergency. Informed consent was obtained from parents. Demographics (name, age of child, sex of the child, duration of fever, weight, season, socioeconomic status and residence) were noted. Then children were admitted and randomly divided in two groups by using lottery method. In group A, children were given oral 200 mg levofloxacin tablet. In group B, children were given oral 900-1,000 mg ciprofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted. All this information was recorded

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Group A with oral 200 mg levofloxacin tablet	Active comparator	Drug: Levofloxacin	Group A included 180 participants. They were given oral 200 mg levofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted.
Group B with oral 900-1,000 mg ciprofloxacin tablet	Active comparator	Drug: ciprofloxacin	. In group B, children were given oral 900-1,000 mg ciprofloxacin tablet. All children were followed-up pediatric wards for 7 days. If fever was resolved within 5 days (body temperature falls <99oF and remain stable for at least 5 days), then efficacy was labeled. Total time required to resolve fever i.e. body temperature <99oF in all children was also noted

Levofloxacin (Drug): Oral 200 mg levofloxacin tablet
ciprofloxacin (Drug): Oral 900-1,000 mg ciprofloxacin tablet

+Outcome measures

Primary outcomes

Total time required to resolve fever [5 days]: Clinical efficacy involved resolution of fever within 5 days (body temperature falls <99oF and remain stable for at least 5 days). Total time required to resolve fever i.e. body temperature <99oF in all children was also noted.

+Eligibility

Sex: All, ages: 1 Year to 12 Years

Inclusion Criteria:

* Children of age 1-12 years
* Typhoid fever
* Confirmed on blood culture

Exclusion Criteria:

* Recurrent typhoid within 3 months
* Intestinal perforation
* Evidence of progressive or complicated disease
* Inability to swallow oral medication
* Hypersensitivity to trial drugs
* Already taken fluoroquinolone, third generation cephalosporin or macrolide in last week

+Locations (1)

Facility	City	Country	Status
Avicenna Hospital Lahore	Lahore, Punjab Province	Pakistan

+Investigators

Professor Aneela Zareen, MBBS FCPS, Study director, Avicenna Medical And Dental College