Contact information
Type
Scientific
Primary contact
Prof Ron Dagan
ORCID ID
Contact details
Soroka University Medical Center
Beer Sheva
84101
Israel
+972 8 6400547
rdagan@bgu.ac.il
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
Acronym
STOP-CAP
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Amoxicillin
Primary outcome measure
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 outcome measures
No secondary outcome measures
Overall trial start date
01/08/2005
Overall trial end date
31/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
01/08/2005
Recruitment end date
31/07/2008
Locations
Countries of recruitment
Israel
Trial participating centre
Soroka University Medical Center
Beer Sheva
84101
Israel
Sponsor information
Organisation
Soroka University Medical Center, Pediatric Infectious Disease Unit (Israel)
Sponsor details
Beer Sheva
84101
Israel
+972 8 6400547
dudi@bgu.ac.il
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Pediatric Indectious Disease Unit, Soroka University Medical Center.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list