A clinical trial to study efficacy of high dose of oral and parenteral Amoxycillin-Clavunate in severe pneumonia in chidren under five years of age.

A comparative study of high dose of oral and parenteral Amoxycillin-Clavunate in treatment of severe pneumonia in children under five.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000341

Enrollment

165

Registered

2010-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Children with severe pneumonia aged 2-59 months.

Interventions

Intervention1: Amoxycillin-Clavunate: Oral 80 mg/kg/day for 7 days Control Intervention1: Amoxycillin-Clavunate: Intravenous 80 mg/kg/day for 7 days Control Intervention2: Amoxycillin-Clavunate: 80mg/

Eligibility

Inclusion criteria

Inclusion criteria: Patients in age group 2-59 months with a diagnosis of Severe Pneumonia. Severe pneumonia defined as Fever,Cough,Fast breathing (Respiratory rate more than 50 in age group 2-12 months and > 40 in 12-59 months) and Chest Indrawing.

Exclusion criteria

Exclusion criteria: Inability to take orally Bronchial Asthma Allergy to Penicillin Very Severe Pneumonia Grade3,4 PEM Pleural Effusion Congenital Heart Disease Tuberculosis Shock Immunocompromised Patients

Design outcomes

Primary

Measure	Time frame
Resolution of signs and symptoms of pneumonia as fever and TachypneaTimepoint: 7 days	—

Secondary

Measure	Time frame
Fever and Tachypnea at 48 hours. Side effects of Amoxycillin-Clavunate Development of complications as Shock, EmpymaTimepoint: At 48 hours At 7 days	—

Countries

India

Contacts

Public ContactDr Jaswinder Saini

Medical Officer

ndhawan_6144@yahoo.com09815629496

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026