Treatment of community acquired alveolar pneumonia in 6-59 month old children: comparing amoxicillin (80 mg/kg) for 10 days with short course of amoxicillin (80 mg/kg) for 3 days

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59218653

Enrollment

300

Registered

2005-12-21

Start date

2005-08-01

Completion date

Unknown

Last updated

2021-01-25

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

Conditions

Community acquired alveolar pneumonia. Respiratory Pneumonia

Interventions

Randomised controlled trial comparing amoxicillin (80 mg/kg) for 10 days with a short course of amoxicillin (80 mg/kg) for 3 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participation in the study will be all infants and young children who meet the following criteria: 1. Children aged 6-59 months who are residents of the Negev region of southern Israel attending the Soroka emergency room (ER) 2. Provision of informed consent required for follow-up visits (visits 2 and 3) 3. Body temperature measured as 38 °C or higher 4. White blood cells count (WBC): 15,000 cells/ml or higher 5. Chest X-ray with alveolar pneumonia as defined by World Health Organisation (WHO)

Exclusion criteria

Exclusion criteria: 1. Patients received any systemic antimicrobial therapy 2 weeks or less before enrolment 2. Patient candidate for parenteral treatment: a. Patients with sepsis (pneumonia with impaired perfusion, low blood pressure, oliguria, lactic acidosis, impaired consciousness) b. Pleural effusion in X-ray c. Recurrent vomiting per history or following treatment trial in the ER 3. O2 saturation <94% 4. Patients with impaired immune system 5. Patients with two or more episodes of pneumonia in the 12 months prior to current illness 6. Patients with chronic diseases (patients with asthma are included in this study) 7. Patients with other infection sites such as clinical dysentery, urinary tract infection, acute otitis media (proven by tympanocentesis), or suspecting meningitis 8. Patients allergic to penicillin

Design outcomes

Primary

Measure	Time frame
The primary outcome is treatment failure defined as: 1. Any patient who will need the study drug replaced 2. Admission to the pediatric wards due to deterioration in medical condition, both after the first 24 hours following the initiation of treatment	—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Israel

Outcome results

None listed

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