PneumoniaPhase 4NCT02678195
3 Days Versus 5 Days Amoxicillin for Chest-indrawing Childhood Pneumonia in Malawi
A Phase 4 study testing Amoxicillin in people with Pneumonia, run by Save the Children at 2 sites in Malawi.
Trial summary
This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT. Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 2 sitesMalawi
- Study dates
- Mar 2016to Dec 2019
- Phase
- Phase 4
- 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
Who may be able to join
- Male or female, 2 to 59 months of age.
- History of cough <14 days or difficult breathing with chest-indrawing.
- Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to Kamuzu Central Hospital (KCH) for a scheduled study follow-up visit.
Who cannot join
- If chest-indrawing observed at screening resolves after bronchodilator challenge, among those with wheeze at screening.
- Severe respiratory distress (e.g., grunting, nasal flaring, head nodding, or severe chest-indrawing).
- Presence of World Health Organization (WHO) Integrated Management of Childhood Illness (IMCI) danger signs including: lethargy or unconsciousness, convulsions, vomiting everything, or inability to drink or breastfeed.
- Hypoxia (SaO2 < 90% on room air, as assessed by a Lifebox pulse oximeter).
- Stridor when calm.
- HIV-1 seropositivity or HIV-1 exposure, assessed as follows:
Show all 23Show fewer
- An HIV-positive result upon rapid antibody test will exclude any child from this study.
- If a child is less than 12 months or age with a positive rapid test result, the child will be referred to receive additional confirmatory HIV testing (e.g., dried blood spot filter paper test) and follow-up from KCH staff, as per standard of care. Even if the confirmatory HIV testing subsequently shows that child is HIV-negative, he or she will remain excluded from the study.
- If a child is less than 24 months of age and has an HIV-negative result upon rapid antibody test, the child's biological mother's HIV status will need to be assessed. If the mother is HIV-positive, the child will be excluded. If the mother has a documented HIV-negative test result from within the past 6 weeks, the child will be included. If the mother does not have documentation of an HIV-negative test result, she will be tested via rapid antibody testing to determine the child's eligibility for this study.
- If a child is over 24 months of age, an HIV-negative rapid antibody test is required for inclusion in the study.
- Note: If a child has documentation of an HIV-negative test result from within the past 6 weeks, that test result will be used for the child's eligibility assessment according to the algorithm described above.
- Severe acute malnutrition (i.e., weight for height/length < -3 SD, mid-upper arm circumference <115 mm, or edema).
- Possible tuberculosis (coughing for more than 14 days).
- Severe anemia, classified by WHO pocketbook guidelines (i.e., severe palmar pallor or hemoglobin <8.0 g/dL)
- Severe malaria, classified by WHO pocketbook guidelines (e.g., positive malaria rapid diagnostic test (mRDT) with any danger sign, stiff neck, abnormal bleeding, clinical jaundice, or hemoglobinuria)
- 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.
- Hospitalized within 14 days prior to the study.
- 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.
- Any non-pneumonia acute medical illness which requires antibiotic treatment per local standard of care.
- Participation in a clinical study of another investigational product within 12 weeks prior to randomization or planning to begin participation during this study.
- Prior participation in an Innovative Treatments in Pneumonia (ITIP) study 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: Double-blind Randomized Controlled Clinical Trial of 3 Days Versus 5 Days Amoxicillin Dispersible Tablets for Chest-indrawing Childhood Pneumonia Among Children 2-59 Months of Age Presenting to Kamuzu Central Hospital in Lilongwe, Malawi
This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.
- Conditions
- Pneumonia
- Being tested
- Amoxicillin, Placebo
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Oral amoxicillin dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
PlaceboDrug
Placebo dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
| Study group | Role | What they receive |
|---|---|---|
| 3 days amoxicillin + 2 days placebo | Experimental | 3 days amoxicillin DT + 2 days placebo DT in two divided doses based on age bands (500 mg/day for children 2 months up to 12 months, 1000 mg/day for children 12 months up to 3 years, and 1,500 mg/day for children 3 years up to 5 years of age). Receives: Drug: Amoxicillin; Drug: Placebo |
| 5 days amoxicillin | Active comparator | 5 days amoxicillin DT in two divided doses based on age bands (500 mg/day for children 2 months up to 12 months, 1000 mg/day for children 12 months up to 3 years, and 1,500 mg/day for children 3 years up to 5 years of age). Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children failing treatment
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Save the Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, University of Washington
- Responsible party
- Sponsor
- Investigators
- Amy Ginsburg, MD, MPH, Principal investigator, Save the Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678195
- Sponsor's protocol ID
- ITIP2
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2016
- Last updated
- 18 Feb 2021
- Results posted
- No
Publications
Ginsburg AS, May S. Analysis of serious adverse events in a pediatric community-acquired pneumonia randomized clinical trial in Malawi. Sci Rep. 2022 Mar 3;12(1):3538. doi: 10.1038/s41598-022-07582-w.
PubMed 35241775Mvalo 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, Nkwopara E, McCollum ED, Phiri M, Schmicker R, Hwang J, Ndamala CB, Phiri A, Lufesi N, May S. Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children. N Engl J Med. 2020 Jul 2;383(1):13-23. doi: 10.1056/NEJMoa1912400.
PubMed 32609979Ginsburg AS, May SJ, Nkwopara E, Ambler G, McCollum ED, Mvalo T, Phiri A, Lufesi N, Sadruddin S. Methods for conducting a double-blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol. BMC Infect Dis. 2018 Sep 21;18(1):476. doi: 10.1186/s12879-018-3379-z.
PubMed 30241517
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Controlled Clinical Trial of 3 Days Versus 5 Days Amoxicillin Dispersible Tablets for Chest-indrawing Childhood Pneumonia Among Children 2-59 Months of Age Presenting to Kamuzu Central Hospital in Lilongwe, Malawi
- ClinicalTrials.gov ID
- NCT02678195
- Acronym / sponsor ID
- ITIP2
- Conditions
- Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Save the ChildrenUniversity, hospital or other
- Collaborators
- University of North Carolina, University of Washington
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 9 Feb 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 clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 days amoxicillin + 2 days placebo | Experimental | Drug: Amoxicillin, Drug: Placebo3 days amoxicillin DT + 2 days placebo DT in two divided doses based on age bands (500 mg/day for children 2 months up to 12 months, 1000 mg/day for children 12 months up to 3 years, and 1,500 mg/day for children 3 years up to 5 years of age). |
| 5 days amoxicillin | Active comparator | Drug: Amoxicillin5 days amoxicillin DT in two divided doses based on age bands (500 mg/day for children 2 months up to 12 months, 1000 mg/day for children 12 months up to 3 years, and 1,500 mg/day for children 3 years up to 5 years of age). |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female, 2 to 59 months of age.
- History of cough <14 days or difficult breathing with chest-indrawing.
- Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to Kamuzu Central Hospital (KCH) for a scheduled study follow-up visit.
Key exclusion criteria (23 listed)
- If chest-indrawing observed at screening resolves after bronchodilator challenge, among those with wheeze at screening.
- Severe respiratory distress (e.g., grunting, nasal flaring, head nodding, or severe chest-indrawing).
- Presence of World Health Organization (WHO) Integrated Management of Childhood Illness (IMCI) danger signs including: lethargy or unconsciousness, convulsions, vomiting everything, or inability to drink or breastfeed.
- Hypoxia (SaO2 < 90% on room air, as assessed by a Lifebox pulse oximeter).
- Stridor when calm.
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 |
|---|---|---|
| AmoxicillinOral amoxicillin dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily | Drug | 3 days amoxicillin + 2 days placebo, 5 days amoxicillin |
| PlaceboPlacebo dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily | Drug | 3 days amoxicillin + 2 days placebo |
Primary outcome
Proportion of children failing treatment
Time frame: 6 days
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 18 Feb 2021.
- Derived from this study: PubMed 35241775Ginsburg AS, May S. Analysis of serious adverse events in a pediatric community-acquired pneumonia randomized clinical trial in Malawi. Sci Rep. 2022 Mar 3;12(1):3538. doi: 10.1038/s41598-022-07582-w.
- 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 32609979Ginsburg AS, Mvalo T, Nkwopara E, McCollum ED, Phiri M, Schmicker R, Hwang J, Ndamala CB, Phiri A, Lufesi N, May S. Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children. N Engl J Med. 2020 Jul 2;383(1):13-23. doi: 10.1056/NEJMoa1912400.
- Derived from this study: PubMed 30241517Ginsburg AS, May SJ, Nkwopara E, Ambler G, McCollum ED, Mvalo T, Phiri A, Lufesi N, Sadruddin S. Methods for conducting a double-blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol. BMC Infect Dis. 2018 Sep 21;18(1):476. doi: 10.1186/s12879-018-3379-z.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin in people with 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 3 inclusion and 23 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 18 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of children failing treatment (time frame: 6 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 NCT02678195, which also lists 4 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 18 Feb 2021.