Comparison of Efficacy of Oral Amoxicillin Versus Intravenous Ceftriaxone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Community-acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral Amoxicillin

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.

Group Type EXPERIMENTAL

Amoxicillin/CA

Intervention Type DRUG

Patients 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.

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.

Group Type EXPERIMENTAL

IV ceftriaxone

Intervention Type DRUG

Patients 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.

Interventions

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Amoxicillin/CA

Patients 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.

Intervention Type DRUG

IV ceftriaxone

Patients 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.

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No