Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT00133432
Eligibility Criteria:
Inclusion Criteria:
1. Age six months to 36 months inclusive.
2. A primary clinical diagnosis of acute pneumonia, which consists of a child presenting with cough or difficulty breathing with the following features:
1. Tachypnea: Respiratory rate greater than or equal to 50 breaths per minute for children aged 6 months up to 12 months and greater than or equal to 40 breaths per minute for children aged 12 months to 36 months.
2. Fever: Temperature greater than or equal to 37.5 degrees Celsius with an axillary thermometer.
3. Any one of the following signs: Flaring of alae nasi, visible indrawing of the lower chest wall muscles on inspiration, central cyanosis, inability to feed, lethargy, or crepitations, i.e. short crackling noises heard during the inspiratory phase of respiration.
3. Chest x-ray abnormalities consistent with an inflammatory process such as distinctly confined dense abnormality or large pleural effusion (i.e. pneumonia or lower respiratory tract infection), not just any change such as pulmonary edema.
4. Parent/caregiver willing to give informed consent and to allow HIV testing of their child.
5. Child able to take study regimen (zinc supplement/placebo).
6. Parents/caregivers willing to comply with a follow-up study visit.
7. Child is anticipated to survive the episode of pneumonia and has no other serious concomitant medical condition that would affect their ability to survive the acute episode of pneumonia.
Exclusion Criteria:
1. Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic-kwashiorkor, and kwashiorkor), which requires microniutrient supplementation including zinc or any other sign of severe malnutrition.
2. Prior known or current diagnosis of full blown AIDS meeting World Health Organization clinical case definition. Children who are only HIV-positive and have acute pneumonia will not be excluded from the study.
3. Subjects with active tuberculosis.
4. Subjects with active measles.
5. Subjects with known or suspected signs of systemic illness (e.g. sepsis, acute meningitis, hemodynamic instability).
6. Subjects with diarrhea defined as passage of 3 or more loose or watery stools in the past 24 hours.
7. Subjects for which the number of days of illness prior to admission is greater than 3 days.
8. Known intolerance or allergy to zinc or zinc-containing products.
9. Subjects presently receiving zinc supplementation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
36 Months
Study:
NCT00133432
Study Brief:
Protocol Section:
NCT00133432