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Comparison of Efficacy of Oral Amoxicillin Versus Intravenous Ceftriaxone

Efficacy of Oral Amoxicillin in Comparison to Intravenous Ceftriaxone in Treatment of Uncomplicated Community Acquired Pneumonia (Cap) Among Children of Age 2-5 Years of Age

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06532409
Enrollment
114
Registered
2024-08-01
Start date
2024-10-01
Completion date
2025-09-30
Last updated
2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

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.

Interventions

DRUGAmoxicillin/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.

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.

Sponsors

RESnTEC, Institute of Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Free from fever3 daysEfficacy will be labeled yes where fever symptoms are resolved (temperature = 98.6ºF) within 3 days.

Countries

Pakistan

Contacts

Primary ContactAsim Din, FCPS
asimdin@yahoo.com+923360017562

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026