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
Secondary identifying numbers NCH 05004; C6-181-508
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

The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO)
20 Avenue Appia
Geneva
CH-1211
Switzerland

Study information

Study designRandomised, placebo controlled, clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDaily 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) studiedSevere and very severe pneumonia
InterventionChildren 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Elemental zinc
Primary outcome measurePrimary outcome measure will be the proportion of children who become treatment failures on standard antimicrobial therapy.
Secondary outcome measures1. Time to recovery from severe pneumonia
2. Time to discharge (complete cessation of clinical signs of pneumonia)
Overall study start date01/09/2006
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Months
Upper age limit24 Months
SexBoth
Target number of participants492
Key inclusion criteriaChildren 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 criteriaChildren 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 enrolment01/09/2006
Date of final enrolment31/12/2008

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

Sponsor information

The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Research organisation

20 Avenue Appia
Geneva
CH-1211
Switzerland

Website http://www.who.int/child-adolescent-health/
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research organisation

The Department of Child and Adolescent Health (CAH)/World Health Organisation (WHO) (Switzerland)

No information available

John Hopkins University (JHU) (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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