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

ISRCTN	ISRCTN59218653
DOI	https://doi.org/10.1186/ISRCTN59218653
Protocol serial number	001
Sponsor	Soroka University Medical Center
Funder	Pediatric Indectious Disease Unit, Soroka University Medical Center.

Submission date: 14/09/2005
Registration date: 21/12/2005
Last edited: 12/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ron Dagan
Scientific

Soroka University Medical Center
Beer Sheva
84101
Israel

Phone	+972 8 6400547
Email	rdagan@bgu.ac.il

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	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
Study acronym	STOP-CAP
Study objectives	In children aged 6-59 months with community acquired non-complicated alveolar pneumonia, no significant differences in chance for clinical cure will be found between patients treated for 10 days and patients treated for 3 days with amoxicillin 80 mg/kg/day.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Community acquired alveolar pneumonia.
Intervention	Randomised controlled trial comparing amoxicillin (80 mg/kg) for 10 days with a short course of amoxicillin (80 mg/kg) for 3 days.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Amoxicillin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/07/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	59 Months
Sex	All
Target sample size at registration	300
Key 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)
Key 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
Date of first enrolment	01/08/2005
Date of final enrolment	31/07/2008

Locations

Countries of recruitment

Israel

Study participating centre

Soroka University Medical Center

Beer Sheva
84101
Israel

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2014	12/01/2021	Yes	No

Editorial Notes

12/01/2021: Publication reference added.