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 |
| Secondary identifying numbers | 001 |
- 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
Scientific
Soroka University Medical Center
Beer Sheva
84101
Israel
| Phone | +972 8 6400547 |
|---|---|
| rdagan@bgu.ac.il |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/08/2005 |
| Completion date | 31/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 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
84101
Israel
Sponsor information
Soroka University Medical Center
University/education
University/education
Pediatric Infectious Disease Unit
Beer Sheva
84101
Israel
| Phone | +972 8 6400547 |
|---|---|
| dudi@bgu.ac.il | |
"ROR" |
https://ror.org/003sphj24 |
Funders
Funder type
University/education
Pediatric Indectious Disease Unit, Soroka University Medical Center.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
