Innovative Treatments in Pneumonia (ITIP) 3

• Register: ClinicalTrials.gov
• Last refreshed on: 1 March 2021
• Main ID: NCT02960919
• Date of registration: 27/09/2016
• Prospective Registration: Yes
• Primary sponsor: Save the Children
• Public title: Innovative Treatments in Pneumonia (ITIP) 3
• Scientific title: Prospective, Observational Study of Clinical Outcomes Among Children 2 to 59 Months of Age With Childhood Pneumonia and Other Co-morbidities in Lilongwe, Malawi Who Have Been Excluded From Pneumonia Clinical Trials
• Date of first enrolment: October 19, 2016
• Target sample size: 1001
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02960919
• Study type: Observational

Countries of recruitment

Malawi

Contacts

• Name: Amy Ginsburg, MD MPH
• Affiliation: Save the Children, Federation Inc

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female, 2 to 59 months of age.

- Excluded from enrollment in Innovative Treatment in Pneumonia (ITIP) 1 and ITIP2
clinical trials due to presence of any of the following:

- Hypoxia (SaO2 < 90% on room air, as assessed by a pulse oximeter).

- Severe respiratory distress (e.g., presence of grunting, nasal flaring, head nodding,
or severe chest-indrawing).

- Severe malaria, classified by World Health Organization (WHO) guidelines on hospital
care for children, including a positive malaria rapid antibody test result.

- Severe anemia, classified by WHO Integrated Management of Childhood Illness (IMCI)
guidelines (i.e., severe palmar pallor) only if a positive malaria rapid antibody test
result.

- severe acute malnutrition (SAM) (i.e., weight for height/length < -3 SD, mid-upper arm
circumference (MUAC) <115, or edema).

- HIV-1 seropositivity or HIV-1 exposure, assessed as follows: An HIV-positive result
upon rapid antibody testing.

- If a child is less than 24 months of age and has an HIV-negative result upon rapid
antibody test documented from the past three months, the child's biological mother's
HIV status will need to be assessed. If the mother is HIV-positive, the child will be
included. If the mother does not have documentation of an HIV-negative test result
from the past 3 months, she will be tested via rapid antibody testing to determine the
child's eligibility for this study.

- Ability and willingness of child's caregiver to provide informed consent and to be
available for follow-up (in the inpatient ward, returning to KCH for a scheduled study
follow-up visit, and by phone) for the planned duration of the study.

Exclusion Criteria:

- Possible tuberculosis (coughing for more than 14 days).

- Stridor when calm.

- Severe anemia, classified by WHO IMCI guidelines (i.e., severe palmar pallor) if a
negative malaria rapid antibody test result.

- Known allergy to penicillin or amoxicillin.

- Receipt of an antibiotic treatment in the 48 hours prior to the study based on
caregiver's self-report and/or documentation in child's medical record.

- Living outside Lilongwe urban area, the study catchment area.

- Any medical or psychosocial condition or circumstance that, in the opinion of the
investigators, would interfere with the conduct of the study or for which study
participation might jeopardize the child's health.

- Participation in a clinical study of an investigational product within 12 weeks prior
to enrollment or planning to begin participation during this study.

- Prior participation in ITIP1, ITIP2 or ITIP3 during a previous pneumonia diagnosis.



Age minimum: 2 Months
Age maximum: 59 Months
Gender: All

Health Condition(s) or Problem(s) studied

Pneumonia

Intervention(s)

Drug: gentamicin

Drug: parenteral ampicillin/ penicillin

Drug: oral amoxicillin or parenteral ampicillin/ penicillin and gentamicin

Primary Outcome(s)

Clinical outcomes: cured, not cured [Time Frame: 14 days]

Secondary ID(s)

ITIP3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Malawi College of Medicine

University of North Carolina

Kamuzu Central Hospital

University of Washington