ISRCTN - ISRCTN59218653: 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

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Sponsor details

Pediatric Infectious Disease Unit
Beer Sheva
84101
Israel
+972 8 6400547
dudi@bgu.ac.il