Multicentre prospective randomised clinical trial to compare the safety and efficacy of outpatient treatment with oral amoxicillin with that of injectable ampicillin in children aged 3 to 59 months: APPIS II Randomised Controlled Trial (RCT), Pakistan
| ISRCTN | ISRCTN95821329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95821329 |
| ClinicalTrials.gov number | NCT00227331 |
| Secondary identifying numbers | RPC116 |
- Submission date
- 31/03/2006
- Registration date
- 31/03/2006
- Last edited
- 15/01/2008
- 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
Dr Shamim Ahmad Qazi
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 791 4853 |
|---|---|
| qazis@who.in |
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 | |
| Study acronym | APPIS II |
| Study objectives | The proportion of children aged 3 to 59 months with World Health Organization (WHO) defined severe pneumonia who fail treatment in the oral amoxicillin group will not be greater than the proportion of those who fail in the parenteral ampicillin group. |
| Ethics approval(s) | Approval received from: 1. Local ethics board on the 2nd December 2004 2. WHO Ethics Research Committee (ERC) on the 23rd March 2005 |
| Health condition(s) or problem(s) studied | World Health Organization (WHO) defined severe pneumonia |
| Intervention | 1. Parenteral Ampicillin for 2 days then sent home on oral amoxicillin for 3 days 2. Oral Amoxicillin for 5 days |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amoxicillin, ampicillin |
| Primary outcome measure | 1. Clinical deterioration occurring any time after enrolment 2. Inability to take oral medication due to persisting vomiting as assessed by study physician 3. Change or addition of antibiotics |
| Secondary outcome measures | 1. Treatment failure between day 6 and 14 2. Clinical deterioration (development of danger signs) between day 6 and 14 3. Development of lower chest indrawing or fast breathing, which is non responsive to three trials of nebulisation with bronchodilator between day 6 and 14 |
| Overall study start date | 24/02/2005 |
| Completion date | 31/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 2100 |
| Key inclusion criteria | 1. Children aged 3 to 59 months with severe pneumonia. Severe pneumonia is defined as Lower Chest Indrawing (LCI) in children with cough and/or difficult breathing, who are able to drink and do not have central cyanosis, regardless of the respiratory rate 2. Known Human Immunodeficiency Virus (HIV) infected patients in clinical category N or A (Centers for Disease Control [CDC]) will be included 3. Informed consent by a legal guardian |
| Key exclusion criteria | Children with any of the following conditions will be excluded: 1. Very severe pneumonia/disease 2. Known prior episodes of asthma or three or more prior episodes of wheezing 3. LCI that resolves after three doses of bronchodilator therapy 4. Severe malnutrition (visible severe wasting or oedema) 5. Known anaphylactic reaction to penicillin or amoxicillin 6. Hospitalisation in the last two weeks 7. Other diseases requiring antibiotic therapy at presentation, such as meningitis, dysentery, osteomyelitis, septic arthritis, evident tuberculosis etc. 8. Persistent vomiting 9. Previous inclusion in the study 10. Living outside a pre-defined area 11. Parental or caretaker refusal to participate in the study |
| Date of first enrolment | 24/02/2005 |
| Date of final enrolment | 31/08/2008 |
Locations
Countries of recruitment
- Pakistan
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Sponsor information
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 791 4853 |
|---|---|
| qazis@who.int | |
| Website | http://www.who.int |
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
No information available
US Agency for International Development (USAID) (USA)
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 | 05/01/2008 | Yes | No |
