Pneumonia, Malaria
Conditions
Keywords
community health care, community health worker, malaria, pneumonia, rapid diagnostic test
Brief 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.
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..
Interventions
DRUGCoartem and amoxicillin
Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
DRUGCoartem
Give Coartem without RDT and refer fast breathing
Sponsors
Center for International Health and Development
United States Agency for International Development (USAID)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Age between 6 months and 5 years * Present with history of fever or reported fever * Present with cough or difficult breathing
Exclusion criteria
* Age below 6 months and above 5 years * Presence of signs and symptoms of severe illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Children Who Received Early and Appropriate Treatment for Pneumonia. | 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) | one year | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Children Who do Not Respond to Treatment for Pneumonia | one year |
Countries
Zambia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,017 |
| 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. | 2,108 |
| Total | 3,125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Hospitalized | 4 | 14 |
| Overall Study | Lost to Follow-up | 35 | 39 |
Baseline characteristics
| Characteristic | Current Practice | Enhanced Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2108 Participants | 1017 Participants | 3125 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 23.6 months STANDARD_DEVIATION 14.7 | 22.6 months STANDARD_DEVIATION 14 | 23.3 months STANDARD_DEVIATION 14.5 |
| Region of Enrollment Zambia | 2108 participants | 1017 participants | 3125 participants |
| Sex: Female, Male Female | 1028 Participants | 484 Participants | 1512 Participants |
| Sex: Female, Male Male | 1080 Participants | 533 Participants | 1613 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 973 | 0 / 2,018 |
| serious Total, serious adverse events | 6 / 1,017 | 15 / 2,108 |
Outcome results
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
Time frame: one year
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Treatment | Number of Children Who Received Early and Appropriate Treatment for Pneumonia. | 247 partcipants |
| Current Practice | Number of Children Who Received Early and Appropriate Treatment for Pneumonia. | 27 partcipants |
95% CI: [2.19, 8.94]
Primary
Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)
Time frame: one year
Population: The participants analyzed was based on children reported with fever. Analysis was per intention to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Treatment | Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) | 265 participants |
| Current Practice | Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) | 2066 participants |
95% CI: [0.14, 0.38]
Secondary
Number of Children Who do Not Respond to Treatment for Pneumonia
Time frame: one year
Population: Based on number classified as having pneumonia. Analysis was per intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Treatment | Number of Children Who do Not Respond to Treatment for Pneumonia | 41 participants |
| Current Practice | Number of Children Who do Not Respond to Treatment for Pneumonia | 41 participants |
95% CI: [0.21, 0.93]