Comparison of Efficacy of Oral Amoxicillin Versus Intravenous Ceftriaxone

Not Applicable

Not yet recruiting

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: IV ceftriaxone; Drug: Amoxicillin/CA

• Registration Number: NCT06532409
• Lead Sponsor: RESnTEC, Institute of Research

Brief Summary

The efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. Also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of IV trauma and infection, which is a major problem in developing countries. Therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (IV) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

Detailed Description

The efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. Also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of IV trauma and infection, which is a major problem in developing countries. Therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (IV) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Study Start: 2024-10-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Children of both gender
• Aged from 2 to 5 years
• With fever >37.5 C (99.5 F)
• Will be presented with symptoms and signs of uncomplicated community acquired pneumonia

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Exclusion Criteria

• Children requiring ICU care (having cyanosis SpO2 < 85% requiring intubation within first day of admission or in state of shock)
• Children with conditions like congenital heart disease, chronic lung disease, chronic kidney disease, severe malnutrition, asthma, foreign bodies, sickle cell disease, and immunodeficiency
• Children with underlying anatomical disorders of the lung like pulmonary sequestration, tracheoesophageal fistula or congenital cystic adenoid malformation
• Children already on antibiotics
• Presence of any complication of community acquired pneumonia
• Patients having symptoms of multi-organ involvement/sepsis
• Hypersensitivity to Amoxicillin or Ceftriaxone
• Other co-existing infections like dengue, malaria, or measles

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Ceftriaxone	IV ceftriaxone	Patients in this group will receive IV ceftriaxone at a dose of 75 mg per kg per day in 2 divided doses for a maximum period of 7 days.
Oral Amoxicillin	Amoxicillin/CA	Patients in this group will receive IV amoxicillin/CA at a dose of 100 mg per kg per day in 3 divided doses for a maximum period of 7 days.

Primary Outcome Measures

Name	Time	Method
Free from fever	3 days	Efficacy will be labeled yes where fever symptoms are resolved (temperature = 98.6ºF) within 3 days.

Trial Locations

Locations (1)

Children Hospital; 🇵🇰 Lahore, Punjab, Pakistan