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

Avicenna Medical College Lahore

Status and phase: Completed; Phase 2

Conditions: Fever; Typhoid

Treatments: Drug: Levofloxacin; Drug: ciprofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT07150065

107

Details and patient eligibility

About

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

Enrollment: 360 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Group A with oral 200 mg levofloxacin tablet

Active Comparator group

Description:

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.

Treatment:

Drug: Levofloxacin

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

Active Comparator group

Description:

. 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

Treatment:

Drug: ciprofloxacin