Trial Outcomes & Findings for Artemisinin-Based Combination Therapy: Clinical Trials in Cameroon (NCT NCT00297882)
NCT ID: NCT00297882
Last Updated: 2021-06-08
Results Overview
To evaluate the safety and antimalarial efficacy of two drug combinations: Artemether-Lumefantrine (AL) and Amodiaquine-Artesunate (AQ - AS) in Camaroonian patients in Mutengene, Bangolan and Garoua
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
816 participants
Primary outcome timeframe
Day 0 - 28
Results posted on
2021-06-08
Participant Flow
Eight hundred and sixteen children aged 6-120 months with uncomplicated falciparum malaria were studied in three ecological different regions of Cameroon - Mutengene (Littoral equatorial forest), Bangolan (Rice farming guinea-savanna) and Garoua (Guinea-savannah).
Participant milestones
| Measure |
1 Artemether-Lumefantrine
Drug: Artemether-Lumefantrine, Artemether-Lumefantrine(Co-Artem) =Artemether, 2mg/kg x 2 (12H apart)/Lumefantrine, 12mg/kgx2 (12H apart).
Other Names: • CoArtem,
|
2 Amodiaquine- Artesunate
Drug: Amodiaquine-Artesunate Amodiaquine-Artemether - administration D0 (0H), D1 (24H), D2 (48H)- Artesunate 4mg/kg \& Amodiaquine at 10mg/kg Other Names: • Arsucam
|
|---|---|---|
|
Day 14
STARTED
|
204
|
612
|
|
Day 14
COMPLETED
|
192
|
563
|
|
Day 14
NOT COMPLETED
|
12
|
49
|
|
Day 28
STARTED
|
192
|
563
|
|
Day 28
COMPLETED
|
176
|
540
|
|
Day 28
NOT COMPLETED
|
16
|
23
|
Reasons for withdrawal
| Measure |
1 Artemether-Lumefantrine
Drug: Artemether-Lumefantrine, Artemether-Lumefantrine(Co-Artem) =Artemether, 2mg/kg x 2 (12H apart)/Lumefantrine, 12mg/kgx2 (12H apart).
Other Names: • CoArtem,
|
2 Amodiaquine- Artesunate
Drug: Amodiaquine-Artesunate Amodiaquine-Artemether - administration D0 (0H), D1 (24H), D2 (48H)- Artesunate 4mg/kg \& Amodiaquine at 10mg/kg Other Names: • Arsucam
|
|---|---|---|
|
Day 14
Lack of Efficacy
|
12
|
49
|
|
Day 28
Lost to Follow-up
|
13
|
23
|
|
Day 28
Lack of Efficacy
|
3
|
0
|
Baseline Characteristics
100 did not complete the trial including 4 deaths
Baseline characteristics by cohort
| Measure |
1 Artemether-Lumefantrine
n=204 Participants
Artemether-Lumefantrine , Amodiaquine-Artesunate: 1 Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).
2 Amodiaquine-ArtemetherD0(0H),D1(24H),D2(48H)- Artesunate 4mg/kg and Amodiaquine at 10mg/kg
|
2 Amodiaquine-Artemether
n=612 Participants
Artemether-Lumefantrine , Amodiaquine-Artesunate: 1 Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).
2 Amodiaquine-ArtemetherD0(0H),D1(24H),D2(48H)- Artesunate 4mg/kg and Amodiaquine at 10mg/kg
|
Total
n=816 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.87 months
STANDARD_DEVIATION 28.4 • n=5 Participants • 100 did not complete the trial including 4 deaths
|
50.77 months
STANDARD_DEVIATION 27.33 • n=7 Participants • 100 did not complete the trial including 4 deaths
|
51.82 months
STANDARD_DEVIATION 27.87 • n=5 Participants • 100 did not complete the trial including 4 deaths
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants • 100 did not complete trial, including 4 deaths
|
302 Participants
n=7 Participants • 100 did not complete trial, including 4 deaths
|
406 Participants
n=5 Participants • 100 did not complete trial, including 4 deaths
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants • 100 did not complete trial, including 4 deaths
|
310 Participants
n=7 Participants • 100 did not complete trial, including 4 deaths
|
410 Participants
n=5 Participants • 100 did not complete trial, including 4 deaths
|
|
Region of Enrollment
Cameroon
|
204 participants
n=5 Participants
|
612 participants
n=7 Participants
|
816 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 - 28Population: Children aged 6 months-10 years in different locations in Cameroon.
To evaluate the safety and antimalarial efficacy of two drug combinations: Artemether-Lumefantrine (AL) and Amodiaquine-Artesunate (AQ - AS) in Camaroonian patients in Mutengene, Bangolan and Garoua
Outcome measures
| Measure |
1 Artemether-Lumefantrine AL
n=204 Participants
1Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).
|
2 Amodiaquine-Artesunate AQ-AS
n=612 Participants
2 Amodiaquine-Artesunate 4mg/kg and Amodiaquine at 10mg/kg
|
|---|---|---|
|
Cure Rate on Day 28
|
197 Participants
|
603 Participants
|
SECONDARY outcome
Timeframe: Day 0-14To evaluate antimalarial efficacy of AL and AQ-AS on day 14 post-treatment
Outcome measures
| Measure |
1 Artemether-Lumefantrine AL
n=204 Participants
1Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).
|
2 Amodiaquine-Artesunate AQ-AS
n=612 Participants
2 Amodiaquine-Artesunate 4mg/kg and Amodiaquine at 10mg/kg
|
|---|---|---|
|
Cure Rate Day 14
|
192 Participants
|
563 Participants
|
Adverse Events
1 Artemether-Lumefantine (AL)
Serious events: 6 serious events
Other events: 105 other events
Deaths: 2 deaths
2 Amodiaquine-Artesunate (AQ-AS)
Serious events: 3 serious events
Other events: 272 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
1 Artemether-Lumefantine (AL)
n=204 participants at risk
Study group 1. Subjects in this group received treatment with Artemether-Lumefantrine. Children received 2 mg/kg Artemether and 12 mg/kg Lumefrantrine with milk twice daily (or every 12 hours for 3 days.
|
2 Amodiaquine-Artesunate (AQ-AS)
n=612 participants at risk
Study group 2. Subjects in this group received treatment with Amodiaquine-Artesunate. Children received a co-administered combination of 30 mg/kg Amodiaquine (AQ) plus 4 mg/kg Artesunate (AS) daily for 3 days.
|
|---|---|---|
|
Infections and infestations
Event leading to death
|
0.98%
2/204 • Number of events 2 • 28 days following treatment.
|
0.33%
2/612 • Number of events 2 • 28 days following treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/204 • 28 days following treatment.
|
0.16%
1/612 • Number of events 1 • 28 days following treatment.
|
|
Infections and infestations
Blackwater fever
|
0.49%
1/204 • Number of events 1 • 28 days following treatment.
|
0.00%
0/612 • 28 days following treatment.
|
|
Hepatobiliary disorders
Hemoglobinuria
|
1.5%
3/204 • Number of events 3 • 28 days following treatment.
|
0.00%
0/612 • 28 days following treatment.
|
Other adverse events
| Measure |
1 Artemether-Lumefantine (AL)
n=204 participants at risk
Study group 1. Subjects in this group received treatment with Artemether-Lumefantrine. Children received 2 mg/kg Artemether and 12 mg/kg Lumefrantrine with milk twice daily (or every 12 hours for 3 days.
|
2 Amodiaquine-Artesunate (AQ-AS)
n=612 participants at risk
Study group 2. Subjects in this group received treatment with Amodiaquine-Artesunate. Children received a co-administered combination of 30 mg/kg Amodiaquine (AQ) plus 4 mg/kg Artesunate (AS) daily for 3 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
26.0%
53/204 • Number of events 53 • 28 days following treatment.
|
22.7%
139/612 • Number of events 139 • 28 days following treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.2%
29/204 • Number of events 29 • 28 days following treatment.
|
15.2%
93/612 • Number of events 93 • 28 days following treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.4%
15/204 • Number of events 15 • 28 days following treatment.
|
3.3%
20/612 • Number of events 20 • 28 days following treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.4%
9/204 • Number of events 9 • 28 days following treatment.
|
3.3%
20/612 • Number of events 20 • 28 days following treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.3%
25/204 • Number of events 25 • 28 days following treatment.
|
10.3%
63/612 • Number of events 63 • 28 days following treatment.
|
|
Gastrointestinal disorders
Anorexia
|
15.2%
31/204 • Number of events 31 • 28 days following treatment.
|
20.1%
123/612 • Number of events 123 • 28 days following treatment.
|
|
Skin and subcutaneous tissue disorders
Itching
|
1.5%
3/204 • Number of events 3 • 28 days following treatment.
|
2.0%
12/612 • Number of events 12 • 28 days following treatment.
|
|
Skin and subcutaneous tissue disorders
Cuteneous eruptions
|
1.5%
3/204 • Number of events 3 • 28 days following treatment.
|
3.4%
21/612 • Number of events 21 • 28 days following treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
15.7%
32/204 • Number of events 32 • 28 days following treatment.
|
3.4%
21/612 • Number of events 21 • 28 days following treatment.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
15/204 • Number of events 15 • 28 days following treatment.
|
3.8%
23/612 • Number of events 23 • 28 days following treatment.
|
Additional Information
Professor Wilfred Mbacham
University of Yaounde 1, Cameroon
Phone: +237 677579180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place