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

Completed

• Conditions: Severe and very severe pneumonia; Infections and Infestations; Pneumonia

• Registration Number: ISRCTN48954234
• Lead Sponsor: The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 492

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure will be the proportion of children who become treatment failures on standard antimicrobial therapy.

Secondary Outcome Measures

Name	Time	Method
1. Time to recovery from severe pneumonia<br>2. Time to discharge (complete cessation of clinical signs of pneumonia)