Phase 3
N=2,628
CHIZAP: Community- and Health Facility-Based Intervention With Zinc as Adjuvant Therapy for Childhood Pneumonia
Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT00148733 ↗Enrolled (actual)
2,628
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Risk of Treatment Failure. — 267; 253 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zinc (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Centre For International Health
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Risk of Treatment Failure. |
267; 253 | — |
| PRIMARY Non-injury Clinic Visits and Hospital Admissions After Treatment Has Been Initiated |
— | — |
| PRIMARY Active and Passive Morbidity Surveillance for Six Months After the 14-day Supplementation Period is Completed |
— | — |
| PRIMARY Difference in Growth and Thymic Size Between the Treatment Groups Measured at Three and Six Months After the Zinc Supplementation |
— | — |
| PRIMARY Adverse Effects |
— | — |
| SECONDARY Effect Modifiers for the Effect of Zinc Given During Pneumonia |
— | — |
| SECONDARY The Efficacy of Zinc According to Breast Feeding Status and in Different Age Categories |
— | — |
| SECONDARY The Efficacy of Zinc in Malnourished and Non-malnourished Children |
— | — |
| SECONDARY Will Presence of a RNA Virus Modify the Effect of Zinc |
— | — |
| SECONDARY Folate, Cobalamin and Vitamin D Status of the Enrolled Children |
— | — |
Summary
The aim of the study described is to measure the degree with which zinc given as adjunct therapy to standard antibiotic treatment during childhood pneumonia reduces the risk of treatment failure and the duration of the illness.
Eligibility Criteria
Inclusion Criteria
- Pneumonia: Child presenting with cough or difficult breathing and elevated respiratory rate.
- Severe pneumonia: Child presenting with cough or difficult breathing and chest indrawing , but without any of the following danger signs:
- not able to drink/breastfeed,
- vomit everything,
- has had convulsions,
- is lethargic or unconscious.
- Must be able to take Zinc
Exclusion Criteria
- The child requires special care for severe illness other than pneumonia
- Severe malnutrition defined as being < 70% National Center for Health Statistics (NCHS) median weight for height
- Presence of congenital heart disease
- Documented tuberculosis
- Any antibiotic treatment during the last 48 hours
- The child was enrolled less than 6 months ago
- Presence of dysentery
- Cough for more than 14 days
Data sourced from ClinicalTrials.gov (NCT00148733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.