Comparison of Efficacy of Oral Amoxicillin Versus Intravenous Ceftriaxone

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-5
SponsorRESnTEC, Institute of Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amoxicillin/CA

    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

    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.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Oral AmoxicillinExperimental treatment 1 intervention
Group B: IV CeftriaxoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Free from fever

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

Time frame
3 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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