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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN48954234

Enrollment

492

Registered

2007-04-23

Start date

2006-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe and very severe pneumonia Infections and Infestations Pneumonia

Interventions

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 Bhatnag

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Primary outcome measure will be the proportion of children who become treatment failures on standard antimicrobial therapy.	—

Secondary

Measure	Time frame
1. Time to recovery from severe pneumonia 2. Time to discharge (complete cessation of clinical signs of pneumonia)	—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026