Comparison of Efficacy of Oral Amoxicillin Versus Intravenous Ceftriaxone

RESnTEC, Institute of Research

Status: Not yet enrolling

Conditions: Community-acquired Pneumonia

Treatments: Drug: IV ceftriaxone; Drug: Amoxicillin/CA

Study type: Interventional

Funder types: Other

Identifiers

NCT06532409

DrAsimCHL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Oral Amoxicillin

Experimental group

Description:

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.

Treatment:

Drug: Amoxicillin/CA

IV Ceftriaxone

Experimental group

Description:

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.

Treatment:

Drug: IV ceftriaxone