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| Name | Class |
|---|---|
| Center for International Health and Development | OTHER |
| United States Agency for International Development (USAID) | FED |
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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coartem and amoxicillin | Drug | Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | one year |
| Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Children Who do Not Respond to Treatment for Pneumonia | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kojo Yeboah-Antwi, MD, MPH | Center for International Health and Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chikankata Health Services | Chikankata | Southern Province | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20877714 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Treatment | Intervention: Treatment for malaria and pneumonia: Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days. Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days. |
| FG001 | Current Practice | Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days. Refer children with pneumonia to the nearest health facility. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Treatment | Intervention: Treatment for malaria and pneumonia: Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days. Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The number of participants determined for this analysis was based on those classified as pneumonia. The analysis was based on an intent-to-treat basis. | Posted | Number | partcipants | one year |
|
1 year
Patients were followed up on Day 5-7 and caregivers were specifically asked about adverse events and documented on a case report form.
The participants at risk to RDT related adverse events in the Enhanced Treatment Arm were 973 because RDT was not done on 44 subjects (no fever = 36; refused = 6; and poor light at the time of visit =2).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Treatment | Intervention: Treatment for malaria and pneumonia: Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days. Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deaths | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RDT related | Skin and subcutaneous tissue disorders | Systematic Assessment | These adverse effects with related to pricking the finger to take blood for rapid diagnostic test |
Imbalance in enrollment. More patients enrolled in the control arm possibly due to many control community health workers working full time and available to see patients all day.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kojo Yeboah-Antwi | Boston University | 617-414-1275 | kyantwi@bu.edu |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077611 | Artemether, Lumefantrine Drug Combination |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
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| Coartem | Drug | Give Coartem without RDT and refer fast breathing |
|
| Hospitalized |
|
| BG001 | Current Practice | Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days. Refer children with pneumonia to the nearest health facility. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Current Practice | Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days. Refer children with pneumonia to the nearest health facility. |
|
|
|
| Primary | Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) | The participants analyzed was based on children reported with fever. Analysis was per intention to treat. | Posted | Number | participants | one year |
|
|
|
|
| Secondary | Number of Children Who do Not Respond to Treatment for Pneumonia | Based on number classified as having pneumonia. Analysis was per intention to treat | Posted | Number | participants | one year |
|
|
|
|
| 6 |
| 1,017 |
| 16 |
| 973 |
| EG001 | Current Practice | Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days. Refer children with pneumonia to the nearest health facility. | 15 | 2,108 | 0 | 2,018 |
| Hospitalization | Infections and infestations | Non-systematic Assessment |
|
|
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| D011528 |
| Protozoan Infections |
| D010272 | Parasitic Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007287 |
| Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |