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Innovative Treatments in Pneumonia (ITIP) 3

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ClinicalTrials.gov Identifier: NCT02960919
Recruitment Status : Completed
First Posted : November 10, 2016
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
University of Washington
University of North Carolina, Project Lilongwe Medical Relief Trust Fund
Kamuzu Central Hospital
University of Malawi College of Medicine
Information provided by (Responsible Party):
Save the Children

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
Pneumonia Drug: oral amoxicillin or parenteral ampicillin/ penicillin and gentamicin Drug: parenteral ampicillin/ penicillin Drug: gentamicin

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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 : October 19, 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. Clinical outcomes: cured, not cured [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children 2 to 59 months of age who present to Kamuzu Central Hospital or Bwaila District Hospital with fast-breathing pneumonia or chest-indrawing pneumonia and other co-morbidities, or severe pneumonia AND are excluded from ITIP1 and ITIP2
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960919


Locations
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Malawi
Bwaila District Hospital
Lilongwe, Malawi
Kamuzu Central Hospital
Lilongwe, Malawi
Sponsors and Collaborators
Save the Children
University of Washington
University of North Carolina, Project Lilongwe Medical Relief Trust Fund
Kamuzu Central Hospital
University of Malawi College of Medicine
Investigators
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Principal Investigator: Amy Ginsburg, MD MPH Save the Children, Federation Inc

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Responsible Party: Save the Children
ClinicalTrials.gov Identifier: NCT02960919     History of Changes
Other Study ID Numbers: ITIP3
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Ampicillin
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Gentamicins
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action