Trial Outcomes & Findings for TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014 (NCT NCT04222088)
NCT ID: NCT04222088
Last Updated: 2023-07-21
Results Overview
The classification of treatment outcomes will be based on an assessment of the parasitological and clinical outcomes of antimalarial treatment according to the latest guidelines of WHO. Accordingly, all patients will be classified as having an Early Treatment Failure by microscopy results P without PCR correction * Development of danger signs or severe malaria on day 1, day 2, or day 3 in the presence of parasitemia; * Parasitaemia on day 2 higher than day 0 count irrespective of axillary temperature; * Parasitaemia on day 3 with axillary temperature ≥37.5 ºC; * Parasitaemia on day 3 ≥25% of count on day 0.
COMPLETED
159 participants
Day 1-3
2023-07-21
Participant Flow
Study Sites: 1. Rural Health Unit, Bataraza, Palawan 2. Rural Health Unit, Rizal, Palawan 3. Rural Health Unit, Brooke's Point Palawan Study Period: May 2013 - December 2014
The number of total patients enrolled/started (159) is different from the total number of patients who completed the study (149) due to lost to follow-up and withdrawal of the patients in the middle of the study. Thus, all 159 patients have baseline characteristics and adverse effects, but only 149 patients who completed the study have outcome measurements.
Participant milestones
| Measure |
Artemether-lumefantrine (Coartem™) + Primaquine
Administered to patients with mono-infection of Plasmodium falciparum with 1000-100 000 asexual forms per µl. Coartem™: 20/120 mg per tablet was administered 3 days (Days 0, 1 and 2) according to body weight. For patients with weight of 5 to \<15kg, 15 to \<25kg, 25 to \<35kg, or ≥35kg, tablets of 1, 2, 3, or 4 will be given respectively. At day 3, primaquine at 0.75 mg base/kg body weight single dose will be given .
|
Chloroquine + Primaquine
Administered to patients with mono-infection of Plasmodium vivax with parasite count of ≥ 250 per µl, Chloroquine 150 mg base tablet was administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2). After 28 days of follow-up, primaquine will be given for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
75
|
|
Overall Study
COMPLETED
|
75
|
74
|
|
Overall Study
NOT COMPLETED
|
9
|
1
|
Reasons for withdrawal
| Measure |
Artemether-lumefantrine (Coartem™) + Primaquine
Administered to patients with mono-infection of Plasmodium falciparum with 1000-100 000 asexual forms per µl. Coartem™: 20/120 mg per tablet was administered 3 days (Days 0, 1 and 2) according to body weight. For patients with weight of 5 to \<15kg, 15 to \<25kg, 25 to \<35kg, or ≥35kg, tablets of 1, 2, 3, or 4 will be given respectively. At day 3, primaquine at 0.75 mg base/kg body weight single dose will be given .
|
Chloroquine + Primaquine
Administered to patients with mono-infection of Plasmodium vivax with parasite count of ≥ 250 per µl, Chloroquine 150 mg base tablet was administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2). After 28 days of follow-up, primaquine will be given for 14 days.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
Analysis of population was categorically subdivided depending on the period of enrollment
Baseline characteristics by cohort
| Measure |
Artemether-lumefantrine (Coartem™) + Primaquine
n=84 Participants
Administered to patients with mono-infection of Plasmodium falciparum with 1000-100 000 asexual forms per µl. Coartem™: 20/120 mg per tablet was administered 3 days (Days 0, 1 and 2) according to body weight. For patients with weight of 5 to \<15kg, 15 to \<25kg, 25 to \<35kg, or ≥35kg, tablets of 1, 2, 3, or 4 will be given respectively. At day 3, primaquine at 0.75 mg base/kg body weight single dose will be given.
|
Chloroquine + Primaquine
n=75 Participants
Administered to patients with mono-infection of Plasmodium vivax with parasite count of ≥ 250 per µl, Chloroquine 150 mg base tablet was administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2). After 28 days of follow-up, primaquine will be given for 14 days.
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.52 years
n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
10.26 years
n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
11.98 years
n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
|
Age, Customized
>15 years old
|
20 Participants
n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
22 Participants
n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
42 Participants
n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
|
Age, Customized
5 - 15 years old
|
48 Participants
n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
24 Participants
n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
72 Participants
n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
|
Age, Customized
<5 years old
|
16 Participants
n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
29 Participants
n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
45 Participants
n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
|
Sex: Female, Male
Female
|
37 Participants
n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
21 Participants
n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
58 Participants
n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
|
Sex: Female, Male
Male
|
47 Participants
n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
54 Participants
n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
101 Participants
n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight (mean, sd)
|
27.23 kg
STANDARD_DEVIATION 15.62 • n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
25.58 kg
STANDARD_DEVIATION 17.72 • n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
26.45 kg
STANDARD_DEVIATION 16.61 • n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
|
Weight (mean, full range)
|
27.23 kg
n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
25.58 kg
n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
26.45 kg
n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
|
Temperature Day 0(mean, SD)
|
38.1 degrees celcius
STANDARD_DEVIATION 1.3 • n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
38.0 degrees celcius
STANDARD_DEVIATION 1.1 • n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
38.0 degrees celcius
STANDARD_DEVIATION 1.2 • n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
|
Temperature Day 0 (mean, full range)
|
38.1 degrees Celcius
n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
38.0 degrees Celcius
n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
38.0 degrees Celcius
n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
|
Parasitemia Day 0
|
16860 uL
n=84 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
5514 uL
n=75 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
9952 uL
n=159 Participants • Analysis of population was categorically subdivided depending on the period of enrollment
|
PRIMARY outcome
Timeframe: Day 1-3Population: Analysis of population is categorically subdivided depending on the period of enrollment of participants to the study
The classification of treatment outcomes will be based on an assessment of the parasitological and clinical outcomes of antimalarial treatment according to the latest guidelines of WHO. Accordingly, all patients will be classified as having an Early Treatment Failure by microscopy results P without PCR correction * Development of danger signs or severe malaria on day 1, day 2, or day 3 in the presence of parasitemia; * Parasitaemia on day 2 higher than day 0 count irrespective of axillary temperature; * Parasitaemia on day 3 with axillary temperature ≥37.5 ºC; * Parasitaemia on day 3 ≥25% of count on day 0.
Outcome measures
| Measure |
Artemether-lumefantrine (Coartem™) + Primaquine
n=75 Participants
Administered to patients with mono-infection of Plasmodium falciparum with 1000-100 000 asexual forms per µl. Coartem™: 20/120 mg per tablet was administered 3 days (Days 0, 1 and 2) according to body weight. For patients with weight of 5 to \<15kg, 15 to \<25kg, 25 to \<35kg, or ≥35kg, tablets of 1, 2, 3, or 4 will be given respectively. At day 3, primaquine at 0.75 mg base/kg body weight single dose will be given.
|
Chloroquine + Primaquine
n=74 Participants
Administered to patients with mono-infection of Plasmodium vivax with parasite count of ≥ 250 per µl, Chloroquine 150 mg base tablet was administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2). After 28 days of follow-up, primaquine will be given for 14 days.
|
|---|---|---|
|
Early Treatment Failure (ETF)
|
0 participants
Interval 0.0 to 4.8
|
0 participants
Interval 0.0 to 4.9
|
PRIMARY outcome
Timeframe: Day 4-28Population: Analysis of population is categorically subdivided depending on the period of enrollment of participants in the study
Patients with late clinical failure without PCR correction: * Development of danger signs or severe malaria on any day from day 4 to day 28 in the presence of parasitaemia, without previously meeting any of the criteria of Early Treatment Failure; * Presence of parasitemia and axillary temperature ≥37.5 ºC (or history of fever in low/moderate transmission areas) on any day from day 4 to day 28, without previously meeting any of the criteria of Early Treatment Failure.
Outcome measures
| Measure |
Artemether-lumefantrine (Coartem™) + Primaquine
n=75 Participants
Administered to patients with mono-infection of Plasmodium falciparum with 1000-100 000 asexual forms per µl. Coartem™: 20/120 mg per tablet was administered 3 days (Days 0, 1 and 2) according to body weight. For patients with weight of 5 to \<15kg, 15 to \<25kg, 25 to \<35kg, or ≥35kg, tablets of 1, 2, 3, or 4 will be given respectively. At day 3, primaquine at 0.75 mg base/kg body weight single dose will be given.
|
Chloroquine + Primaquine
n=74 Participants
Administered to patients with mono-infection of Plasmodium vivax with parasite count of ≥ 250 per µl, Chloroquine 150 mg base tablet was administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2). After 28 days of follow-up, primaquine will be given for 14 days.
|
|---|---|---|
|
Late Clinical Failure (LCF)
|
1 participants
Interval 0.0 to 7.2
|
0 participants
Interval 0.0 to 4.9
|
PRIMARY outcome
Timeframe: day 7 to day 28Population: Analysis of population is categorically subdivided depending on the period of enrollment of participants in the study
Patients with late parasitological failure without PCR correction: • Presence of parasitemia on any day from day 7 to day 28 and axillary temperature \<37.5 ºC, without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure.
Outcome measures
| Measure |
Artemether-lumefantrine (Coartem™) + Primaquine
n=75 Participants
Administered to patients with mono-infection of Plasmodium falciparum with 1000-100 000 asexual forms per µl. Coartem™: 20/120 mg per tablet was administered 3 days (Days 0, 1 and 2) according to body weight. For patients with weight of 5 to \<15kg, 15 to \<25kg, 25 to \<35kg, or ≥35kg, tablets of 1, 2, 3, or 4 will be given respectively. At day 3, primaquine at 0.75 mg base/kg body weight single dose will be given.
|
Chloroquine + Primaquine
n=74 Participants
Administered to patients with mono-infection of Plasmodium vivax with parasite count of ≥ 250 per µl, Chloroquine 150 mg base tablet was administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2). After 28 days of follow-up, primaquine will be given for 14 days.
|
|---|---|---|
|
Late Parasitological Failure (LPF)
|
0 participants
Interval 0.0 to 4.8
|
2 participants
Interval 0.3 to 9.4
|
PRIMARY outcome
Timeframe: Day 0-28Population: Analysis of population is categorically subdivided depending on the period pf enrollment of the participant in the study
Adequate Clinical and Parasitological Response (ACPR): Absence of parasitemia on day 28 irrespective of axillary temperature without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure or Late Parasitological Failure.
Outcome measures
| Measure |
Artemether-lumefantrine (Coartem™) + Primaquine
n=75 Participants
Administered to patients with mono-infection of Plasmodium falciparum with 1000-100 000 asexual forms per µl. Coartem™: 20/120 mg per tablet was administered 3 days (Days 0, 1 and 2) according to body weight. For patients with weight of 5 to \<15kg, 15 to \<25kg, 25 to \<35kg, or ≥35kg, tablets of 1, 2, 3, or 4 will be given respectively. At day 3, primaquine at 0.75 mg base/kg body weight single dose will be given.
|
Chloroquine + Primaquine
n=74 Participants
Administered to patients with mono-infection of Plasmodium vivax with parasite count of ≥ 250 per µl, Chloroquine 150 mg base tablet was administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2). After 28 days of follow-up, primaquine will be given for 14 days.
|
|---|---|---|
|
Adequate Clinical and Parasitological Response (ACPR)
|
74 Participants
|
72 Participants
|
Adverse Events
Artemether-lumefantrine (Coartem™) + Primaquine
Chloroquine + Primaquine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Fe Esperanza Caridad J. Espino
Research Institute for Tropical Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place