Efficacy of zinc (given as an adjunct) in the treatment of severe and very severe pneumonia in hospitalised children 2 to 24 months of age
| ISRCTN | ISRCTN48954234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48954234 |
| Protocol serial number | NCH 05004; C6-181-508 |
| Sponsor | The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland) |
| Funders | The Department of Child and Adolescent Health (CAH)/World Health Organisation (WHO) (Switzerland), John Hopkins University (JHU) (USA) |
- Submission date
- 17/04/2007
- Registration date
- 23/04/2007
- Last edited
- 17/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Olivier Fontaine
Scientific
Scientific
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO)
20 Avenue Appia
Geneva
CH-1211
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo controlled, clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Daily oral administration of 20 mg of elemental zinc given in addition to standard antimicrobial therapy in hospitalised children aged 2 to 35 months admitted with severe pneumonia reduces the proportion of treatment failures by 30% as compared to children receiving standard antimicrobial therapy alone. |
| Ethics approval(s) | Approval received from: 1. Ethics Committee of the All India Institute of Medical Sciences on 03/03/2006 (ref: A-01: 03/02/2006 2. Office of the Medical superintendent, Deen Dayal Upadhyay Hospital on 29/08/2006 (ref: F.19(21)06-DDUH/LIB./9382) 3. Institutional ethics committee of Lady Hardinge Medical College & Associated Hospitals on 21/09/2006 4. World Health Organization Research Ethics Review Committee (WHO ERC) on 22/02/2006 |
| Health condition(s) or problem(s) studied | Severe and very severe pneumonia |
| Intervention | Children will be randomised to receive 20 mg of elemental zinc or placebo each day until discharge, and to be completed at home for a total period of 14 days. Principal investigator: Shinjini Bhatnagar Centre For Diarrhoeal Diseases and Nutrition Research Department of Paediatrics All India Institute of Medical Sciences New Delhi-110029 India Tel.: +91 (0)11 2659 3290 Fax: +91 (0)11 2658 8822 Email: shinjini_bhatnagar@rediffmail.com Second Sponsor: Johns Hopkins Bloomberg School of Public Health 615 N Wolfe Street Baltimore MD 21205-2179 United States of America |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Elemental zinc |
| Primary outcome measure(s) |
Primary outcome measure will be the proportion of children who become treatment failures on standard antimicrobial therapy. |
| Key secondary outcome measure(s) |
1. Time to recovery from severe pneumonia |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Months |
| Upper age limit | 24 Months |
| Sex | All |
| Target sample size at registration | 492 |
| Key inclusion criteria | Children 2 months and up to 24 months of age presenting with a cough or difficult breathing of less than seven days duration with: 1. Fast breathing: 1.1. Greater than 50 breaths per minute in children less than 24 months 1.2. Greater than 40 breaths per minute in children 24 to 35 months 2. Crepitations (on auscultation) 3. Presence of chest indrawing or any general danger sign, i.e., lethargy or inability to drink or central cyanosis (defined as severe pneumonia) |
| Key exclusion criteria | Children with any of the following features will be excluded: 1. Congenital malformations, e.g., hydrocephalus, structural Central Nervous System (CNS) malformation 2. Known structural defects, which interfere with feeding, for example: 2.1. Cleft palate 2.2. Oesophageal abnormalities 2.3. Intestinal atresia and stenosis 2.4. Malrotation of the gut 2.5. Anorectal malformation 3. Subjects requiring ventilation or ionotropic support 4. Known inborn error of metabolism 5. Chronic disorders of other organs, e.g., neonatal cholestasis, chronic renal failure, pre-existing seizure disorder 6. Infants born of known Human Immunodeficiency Viurs (HIV) mothers 7. Congenital heart disease 8. Known case of bronchial asthma 9. Active measles (fever and rash) 10. Severe malnutrition requiring separate medical attention 11. Children receiving zinc supplements 12. Children documented to have received intravenous antimicrobials for more than 48 hours for current illness |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- India
- Switzerland
Study participating centre
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO)
Geneva
CH-1211
Switzerland
CH-1211
Switzerland
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 | 01/06/2013 | Yes | No |
