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

NCT07150065 | Completed Phase 2

• 1 other identifier: 107
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Keywords

ciprofloxacin; children; enteric fever; levofloxacin

Outcome Measures

Primary Outcomes (1)

• Total time required to resolve fever

  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.

  5 days

Study Arms (2)

Group A with oral 200 mg levofloxacin tablet

ACTIVE COMPARATOR

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.

Drug: Levofloxacin

Group B with oral 900-1,000 mg ciprofloxacin tablet

ACTIVE COMPARATOR

. 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

Drug: ciprofloxacin

Interventions

Levofloxacin DRUG

Oral 200 mg levofloxacin tablet

Group A with oral 200 mg levofloxacin tablet

ciprofloxacin DRUG

Oral 900-1,000 mg ciprofloxacin tablet

Group B with oral 900-1,000 mg ciprofloxacin tablet

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avicenna Medical College Lahore: lead

Study Sites (1)

Avicenna Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Typhoid Fever; Fever

Interventions

Levofloxacin; Ciprofloxacin

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Professor Aneela Zareen, MBBS FCPS

  Avicenna Medical And Dental College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: September 2, 2025
• Study Start: February 7, 2025
• Primary Completion: August 7, 2025
• Study Completion: August 7, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)