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

NCT ID: NCT07150065

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-07
• Study Completion Date: 2025-08-07

Brief 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

Conditions

Typhoid; Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A with oral 200 mg levofloxacin tablet

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 Type: ACTIVE_COMPARATOR

Levofloxacin

Intervention Type: DRUG

Oral 200 mg levofloxacin tablet

Group B with oral 900-1,000 mg ciprofloxacin 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

Group Type: ACTIVE_COMPARATOR

ciprofloxacin

Intervention Type: DRUG

Oral 900-1,000 mg ciprofloxacin tablet

Interventions

Levofloxacin

Oral 200 mg levofloxacin tablet

Intervention Type: DRUG

ciprofloxacin

Oral 900-1,000 mg ciprofloxacin tablet

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avicenna Medical College Lahore

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Iqbal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Professor Aneela Zareen, MBBS FCPS

Role: STUDY_DIRECTOR

Avicenna Medical And Dental College

Locations

Avicenna Hospital Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

107

Identifier Type: -

Identifier Source: org_study_id