Innovative Treatments in Pneumonia (ITIP) 3

Sponsor

Save the Children (Other)

Overall Status

Completed

CT.gov ID

NCT02960919

Collaborator

University of Washington (Other), University of North Carolina (Other), Kamuzu Central Hospital (Other), University of Malawi College of Medicine (Other)

1,001

Enrollment

Locations

20.4

Actual Duration (Months)

500.5

Patients Per Site

24.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective observational study assessing the clinical outcomes of children 2 to 59 months of age with both pneumonia and other co-morbidities presenting to a tertiary hospital outpatient setting in Malawi, Africa who are most at risk for mortality or have other complications and thus, are typically excluded from childhood pneumonia studies.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Drug: oral amoxicillin or parenteral ampicillin/ penicillin and gentamicin Drug: parenteral ampicillin/ penicillin Drug: gentamicin

Study Design

Study Type:

Observational

Actual Enrollment :

1001 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

Oct 19, 2016

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Outcome Measures

Primary Outcome Measures

Clinical outcomes: cured, not cured [14 days]
Clinically cured - absence of very fast-breathing, chest-indrawing, hypoxemia, severe respiratory distress (e.g., presence of grunting, nasal flaring, head nodding, or severe chest-indrawing), World Health Organization danger signs (i.e. lethargy or unconsciousness, convulsions, vomiting everything, or inability to drink or breastfeed), and fever: Cured but failed initial antibiotic treatment regimen Cured and did not fail initial antibiotic treatment regimen Not cured: Deteriorating Stable (not improving or deteriorating, prognosis unclear)

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bwaila District Hospital	Lilongwe		Malawi
2	Kamuzu Central Hospital	Lilongwe		Malawi

Sponsors and Collaborators

Save the Children
University of Washington
University of North Carolina
Kamuzu Central Hospital
University of Malawi College of Medicine

Investigators

Principal Investigator: Amy Ginsburg, MD MPH, Save the Children, Federation Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Save the Children

ClinicalTrials.gov Identifier:

NCT02960919

Other Study ID Numbers:

ITIP3

First Posted:

Nov 10, 2016

Last Update Posted:

Feb 21, 2021

Last Verified:

Feb 1, 2021

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2021