Trial Outcomes & Findings for Zambia Integrated Management of Malaria and Pneumonia Study (NCT NCT00513500)
NCT ID: NCT00513500
Last Updated: 2010-07-20
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3125 participants
Primary outcome timeframe
one year
Results posted on
2010-07-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1017
|
2108
|
|
Overall Study
COMPLETED
|
976
|
2054
|
|
Overall Study
NOT COMPLETED
|
41
|
54
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
35
|
39
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Hospitalized
|
4
|
14
|
Baseline Characteristics
Zambia Integrated Management of Malaria and Pneumonia Study
Baseline characteristics by cohort
| Measure |
Enhanced Treatment
n=1017 Participants
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.
|
Current Practice
n=2108 Participants
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.
|
Total
n=3125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1017 Participants
n=93 Participants
|
2108 Participants
n=4 Participants
|
3125 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
22.6 months
STANDARD_DEVIATION 14.0 • n=93 Participants
|
23.6 months
STANDARD_DEVIATION 14.7 • n=4 Participants
|
23.3 months
STANDARD_DEVIATION 14.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
484 Participants
n=93 Participants
|
1028 Participants
n=4 Participants
|
1512 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
533 Participants
n=93 Participants
|
1080 Participants
n=4 Participants
|
1613 Participants
n=27 Participants
|
|
Region of Enrollment
Zambia
|
1017 participants
n=93 Participants
|
2108 participants
n=4 Participants
|
3125 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: 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.
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
Outcome measures
| Measure |
Enhanced Treatment
n=362 Participants
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.
|
Current Practice
n=203 Participants
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.
|
|---|---|---|
|
Number of Children Who Received Early and Appropriate Treatment for Pneumonia.
|
247 partcipants
|
27 partcipants
|
PRIMARY outcome
Timeframe: one yearPopulation: The participants analyzed was based on children reported with fever. Analysis was per intention to treat.
Outcome measures
| Measure |
Enhanced Treatment
n=963 Participants
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.
|
Current Practice
n=2084 Participants
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.
|
|---|---|---|
|
Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)
|
265 participants
|
2066 participants
|
SECONDARY outcome
Timeframe: one yearPopulation: Based on number classified as having pneumonia. Analysis was per intention to treat
Outcome measures
| Measure |
Enhanced Treatment
n=362 Participants
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.
|
Current Practice
n=203 Participants
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.
|
|---|---|---|
|
Number of Children Who do Not Respond to Treatment for Pneumonia
|
41 participants
|
41 participants
|
Adverse Events
Enhanced Treatment
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Current Practice
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enhanced Treatment
n=973 participants at risk；n=1017 participants at risk
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.
|
Current Practice
n=2018 participants at risk；n=2108 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Deaths
|
0.20%
2/1017 • Number of events 1017 • 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).
|
0.05%
1/2108 • Number of events 2108 • 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).
|
|
Infections and infestations
Hospitalization
|
0.39%
4/1017 • Number of events 1017 • 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).
|
0.66%
14/2108 • Number of events 2108 • 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).
|
Other adverse events
| Measure |
Enhanced Treatment
n=973 participants at risk；n=1017 participants at risk
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.
|
Current Practice
n=2018 participants at risk；n=2108 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
RDT related
|
1.6%
16/973 • Number of events 16 • 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).
|
0.00%
0/2018 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place