PneumoniaZIMMAPSNCT00513500
Zambia Integrated Management of Malaria and Pneumonia Study
A study testing Coartem and amoxicillin and Coartem in people with Pneumonia and Malaria, run by Boston University at 1 site in Zambia.
Trial summary
The purpose of the study is to demonstrate the effectiveness and feasibility of community-based management of pneumonia and malaria by community health workers (CHWs) in a rural district of Zambia. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- What is being tested?
- Coartem and amoxicillin and Coartem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,125 participants
- Where
- 1 siteZambia
- Study dates
- Jun 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 6 months and 5 years
- Present with history of fever or reported fever
- Present with cough or difficult breathing
Who cannot join
- Age below 6 months and above 5 years
- Presence of signs and symptoms of severe illness
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to demonstrate the effectiveness and feasibility of community-based management of pneumonia and malaria by community health workers (CHWs) in a rural district of Zambia.
Read the detailed description
Pneumonia and malaria are the two leading causes of morbidity and mortality among children under five in sub-Saharan Africa. Due to limited access to health services in many developing countries, a number of global health organizations, including the World Health Organization, have strongly advocated the use of community health workers (CHWs) to deliver basic health care in the community and to facilitate referral to primary health facilities.
Existing supported CHWs in the study area will be trained in the assessment and classification of children between six months and five years of age presenting with fever and/or cough/difficult breathing. In the intervention arm, CHWs will be supplied with rapid diagnostic tests (RDTs), Coartem (a fixed dose combination of artemether-lumefantrine) and amoxicillin. The intervention CHWs will be trained to use RDTs in patients with reported fever and provide those with a positive result with Coartem; and patients suspected of pneumonia (based on fast breathing) will be treated with amoxicillin as per the standard of care at health facilities and monitored. In the control arm, no RDT will be performed. The CHWs will be supplied with Coartem to treat malaria/febrile illness as per the integrated management of childhood illnesses (IMCI) guidelines and patients suspected of pneumonia will be referred to the health facility for treatment as per the current practice. Data collectors will routinely visit CHWs to collect data on their consultations and follow-up patients treated by CHWs in their homes..
- Being tested
- Coartem and amoxicillin, Coartem
- Keywords
- community health care, community health worker, malaria, pneumonia, rapid diagnostic test
- Medical subject headings
- Pneumonia, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coartem and amoxicillinDrug
Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
CoartemDrug
Give Coartem without RDT and refer fast breathing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Give one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on rapid diagnostic test. For pneumonia, give one half tablet (250mg amoxicillin) for children weighing (5-9.9kg) and one tablet for children weighing (10-20kg) three times a day for five days. Receives: Drug: Coartem and amoxicillin |
| 2 | Active comparator | Give one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on clinical diagnosis. For pneumonia, refer to the nearest health facility Receives: Drug: Coartem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Children Who Received Early and Appropriate Treatment for Pneumonia.
Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom
Measured: one year
Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)
Measured: one year
Secondary outcomes (1)
Number of Children Who do Not Respond to Treatment for Pneumonia
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for International Health and Development, United States Agency for International Development (USAID)
- Investigators
- Kojo Yeboah-Antwi, MD, MPH, Principal investigator, Center for International Health and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513500
- Sponsor's protocol ID
- GHS-A-00-00020-00-5
- Acronym
- ZIMMAPS
- Status last verified
- Jul 2010
- First submitted
- 7 Aug 2007
- Last updated
- 20 Jul 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Yeboah-Antwi K, Pilingana P, Macleod WB, Semrau K, Siazeele K, Kalesha P, Hamainza B, Seidenberg P, Mazimba A, Sabin L, Kamholz K, Thea DM, Hamer DH. Community case management of fever due to malaria and pneumonia in children under five in Zambia: a cluster randomized controlled trial. PLoS Med. 2010 Sep 21;7(9):e1000340. doi: 10.1371/journal.pmed.1000340.
PubMed 20877714
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zambia Integrated Management of Malaria and Pneumonia Study
- ClinicalTrials.gov ID
- NCT00513500
- Acronym / sponsor ID
- ZIMMAPS / GHS-A-00-00020-00-5
- Keywords
- community health care, community health worker, malaria, pneumonia, rapid diagnostic test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,125 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Center for International Health and Development, United States Agency for International Development (USAID)
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Posted 13 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate the effectiveness and feasibility of community-based management of pneumonia and malaria by community health workers (CHWs) in a rural district of Zambia.
Detailed description
Pneumonia and malaria are the two leading causes of morbidity and mortality among children under five in sub-Saharan Africa. Due to limited access to health services in many developing countries, a number of global health organizations, including the World Health Organization, have strongly advocated the use of community health workers (CHWs) to deliver basic health care in the community and to facilitate referral to primary health facilities.
Existing supported CHWs in the study area will be trained in the assessment and classification of children between six months and five years of age presenting with fever and/or cough/difficult breathing. In the intervention arm, CHWs will be supplied with rapid diagnostic tests (RDTs), Coartem (a fixed dose combination of artemether-lumefantrine) and amoxicillin. The intervention CHWs will be trained to use RDTs in patients with reported fever and provide those with a positive result with Coartem; and patients suspected of pneumonia (based on fast breathing) will be treated with amoxicillin as per the standard of care at health facilities and monitored. In the control arm, no RDT will be performed. The CHWs will be supplied with Coartem to treat malaria/febrile illness as per the integrated management of childhood illnesses (IMCI) guidelines and patients suspected of pneumonia will be referred to the health facility for treatment as per the current practice. Data collectors will routinely visit CHWs to collect data on their consultations and follow-up patients treated by CHWs in their homes..
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Coartem and amoxicillinGive one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on rapid diagnostic test. For pneumonia, give one half tablet (250mg amoxicillin) for children weighing (5-9.9kg) and one tablet for children weighing (10-20kg) three times a day for five days. |
| 2 | Active comparator | Drug: CoartemGive one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on clinical diagnosis. For pneumonia, refer to the nearest health facility |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 6 months and 5 years
- Present with history of fever or reported fever
- Present with cough or difficult breathing
Key exclusion criteria (2 listed)
- Age below 6 months and above 5 years
- Presence of signs and symptoms of severe illness
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 |
|---|---|---|
| Coartem and amoxicillinPerform RDT and give Coartem for malaria and give amoxicillin for fast breathing | Drug | 1 |
| CoartemGive Coartem without RDT and refer fast breathing | Drug | 2 |
Primary outcome
Number of Children Who Received Early and Appropriate Treatment for Pneumonia.
Time frame: one year
Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom
Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)
Time frame: one year
1 secondary outcome
Number of Children Who do Not Respond to Treatment for Pneumonia
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20877714Yeboah-Antwi K, Pilingana P, Macleod WB, Semrau K, Siazeele K, Kalesha P, Hamainza B, Seidenberg P, Mazimba A, Sabin L, Kamholz K, Thea DM, Hamer DH. Community case management of fever due to malaria and pneumonia in children under five in Zambia: a cluster randomized controlled trial. PLoS Med. 2010 Sep 21;7(9):e1000340. doi: 10.1371/journal.pmed.1000340.
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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.
Kojo Yeboah-Antwi, MD, MPH principal investigator
Center for International Health and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coartem and amoxicillin and Coartem in people with Pneumonia and Malaria, run by Boston University at 1 site in Zambia.
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 2 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 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Children Who Received Early and Appropriate Treatment for Pneumonia. (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT00513500, which also lists 1 linked publication.
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 20 Jul 2010.