PneumoniaNCT02960919
Innovative Treatments in Pneumonia (ITIP) 3
An observational study of Pneumonia, run by Save the Children at 2 sites in Malawi.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- oral amoxicillin or parenteral ampicillin/ penicillin and gentamicin, parenteral ampicillin/ penicillin and gentamicin
- Type of treatment
- Pill or oral medicine
- How many people
- 1,001 participants
- Where
- 2 sitesMalawi
- Study dates
- 19 Oct 2016to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 59 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Malawi2 sites
Bwaila District Hospital
Lilongwe
Kamuzu Central Hospital
Lilongwe
About this study
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
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.
- Conditions
- Pneumonia
- Being tested
- oral amoxicillin or parenteral ampicillin/ penicillin and gentamicin, parenteral ampicillin/ penicillin, gentamicin
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral amoxicillin or parenteral ampicillin/ penicillin and gentamicinDrug
parenteral ampicillin/ penicillinDrug
gentamicinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes: cured, not cured
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)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start19 Oct 2016
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Save the Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of North Carolina, Kamuzu Central Hospital, Kamuzu University of Health Sciences
- Responsible party
- Sponsor
- Investigators
- Amy Ginsburg, MD MPH, Principal investigator, Save the Children, Federation Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960919
- Sponsor's protocol ID
- ITIP3
- Status last verified
- Feb 2021
- First submitted
- 27 Sep 2016
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Mvalo T, McCollum ED, Fitzgerald E, Kamthunzi P, Schmicker RH, May S, Phiri M, Chirombo C, Phiri A, Ginsburg AS. Chest radiography in children aged 2-59 months enrolled in the Innovative Treatments in Pneumonia (ITIP) project in Lilongwe Malawi: a secondary analysis. BMC Pediatr. 2022 Jan 10;22(1):31. doi: 10.1186/s12887-021-03091-3.
PubMed 35012490Ginsburg AS, Mvalo T, Hwang J, Phiri M, McCollum ED, Maliwichi M, Schmicker R, Phiri A, Lufesi N, May S. Malawian children with fast-breathing pneumonia with and without comorbidities. Pneumonia (Nathan). 2021 Feb 25;13(1):3. doi: 10.1186/s41479-021-00081-y.
PubMed 33627192
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02960919
- Acronym / sponsor ID
- ITIP3
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Save the ChildrenUniversity, hospital or other
- Collaborators
- University of Washington, University of North Carolina, Kamuzu Central Hospital, Kamuzu University of Health Sciences
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 10 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral amoxicillin or parenteral ampicillin/ penicillin and gentamicin | Drug | – |
| parenteral ampicillin/ penicillin | Drug | – |
| gentamicin | Drug | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 35012490Mvalo T, McCollum ED, Fitzgerald E, Kamthunzi P, Schmicker RH, May S, Phiri M, Chirombo C, Phiri A, Ginsburg AS. Chest radiography in children aged 2-59 months enrolled in the Innovative Treatments in Pneumonia (ITIP) project in Lilongwe Malawi: a secondary analysis. BMC Pediatr. 2022 Jan 10;22(1):31. doi: 10.1186/s12887-021-03091-3.
- Derived from this study: PubMed 33627192Ginsburg AS, Mvalo T, Hwang J, Phiri M, McCollum ED, Maliwichi M, Schmicker R, Phiri A, Lufesi N, May S. Malawian children with fast-breathing pneumonia with and without comorbidities. Pneumonia (Nathan). 2021 Feb 25;13(1):3. doi: 10.1186/s41479-021-00081-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Ginsburg, MD MPH principal investigator
Save the Children, Federation Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Save the Children at 2 sites in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes: cured, not cured (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02960919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.