Transcript AMI -RAVREDA – USAID Project report, Colombia March 2009

AMI -RAVREDA – USAID Project
report, Colombia March 2009
Preliminary results on efficacy and
Safety of Coartem® on the treatment
of Acute Uncomplicated
Plasmodium falciparum Malaria
Infections conducted at Malaria
Clinic Georgetown, hospital Region
4 Guyana. 2007-2008
• This study was conducted in Subjects > 10 Kg of a
body-weight with parasitological-confirmed, acute
uncomplicated P. falciparum infections was assigned
treatment with Coartem® (6-dose regimen, according
to WHO recommendation.
• Clinical and parasitological` parameters was
monitored over a 28-day follow-up period to
evaluate the anti-malaria drug efficacy and safety
OBJECTIVES:
(1)
Assess the efficacy and safety of Co-artem®
therapy for the treatment of acute uncomplicated P.
falciparum infections in Georgetown Region 4;
Guyana
(2)
Evaluate the impact of Co-artem® therapy on
gametocytaemia
Study Team:
•Physician as a monitor,
•A Medex to obtain clinical histories and carry out
examinations;
•Senior Field Workers to administer the study
medications and provide patient instructions;
• 2 Laboratory Technicians (Malaria Microscopists) to
take and examine the blood smears
•And a Computer Data Entry Personnel were participants
as a study team.
While all of the personnel will have prior experience with the
protocol, at least one of them will serve as Study Site
Supervisor.
The entire study was constantly and closely monitored by the
Investigators
During the period of the trial (2007-2008)
• Total amount of 8477 smear taken
– 1343 (15.84 %) P. falciparum,
– 1369 (16.14 %), P. vivax
– 62 Malariae (0.73 %),
– 245 mix- infections (2.89 %)
– and 5458 negatives (64.38%).
• A total of 695 patients were screened
• 90 patients were enrolled; 606 were not enrolled
Main reasons for non enrolment of patients into the
Trial. Guyana 2007-2008
Reason for not enrolment
Not available for the study
Living too far
Took anti-malarial drugs
Severe Vomiting
Not return for results
Too high parasite count
Pregnancy
Jaundice
Refused to have RDT
Filaria parasite detected
Total
#
424
83
52
24
12
3
3
3
1
1
606
%
69.96
13.69
8.58
3.96
1.98
0.49
0.49
0.49
0.16
0.16
99.96
Main characteristics of the patients participating in
the trial
In Vivo Study, Frequency By age group, Guyana 2008
7%
0%
9%
0--5
6--15
15--49
50--+
76. 84 % between 15-49 years old,
•Occupation 56 % miner and 14 %
•other activity;
•Gender :male 85.5 % and 15.5 % female,
•Ethnic group,
•37 % Afro-Guyanese,
•33 % Mixed,
•Region visited before the diagnosis
•57 % from region 7,
•13 % from region 10,
•15 % from region 8.
76, 84%
Place of residence and Region visited before the
diagnosis
Region Visited
Region
Frequency
Region 1
Percent
1
4
4,40%
10
13
14,40%
7
57
63,30%
8
15
16,70%
9
1
1,10%
Total
90
100,00%
95 % Residence in R 4
Region 7
Region 10
Region 8
Region 9
Clinical presentation at initial diagnosis
In vivo Study 2007-2008 Guyana
Initial Diagnosis(Thick)
+
++
Frequency
%
11
12,20
%
56
62,20
%
+++
20
<- +/2
3
22,20
%
3,30
%
90
100,0
0%
Total
Frequency of Symptoms reported by the patients recruited, In vivo
study , 2007-2008
Fever
Fever
Frequency
Percent
No
73
81,10%
Yes
17
18,90%
Bodypain
Bodypain
Frequency
Percent
Total
90
100,00%
No
21
23,33
Fdays
Frequency
Percent
Day 0
67
74,44
No
73
82,20%
Days 0-1
1
1,11
Days 1
1
1,11
Day-0
15
16,70%
Total
90
100
Days 0-1
2
1,10%
Total
90
100,00%
Frequency of Symptoms reported by the patients recruited, In
vivo study , 2007-2008
Headache
Diarrea
Headache
Days
Frequency
Percent
No
20
22,20%
Day-0
66
73,30%
Days 0-1
3
3,30%
Days -1
1
1,10%
Total
90
100,00%
Days
Frequency
Percent
No
84
93,30%
Day-0
6
6,70%
Total
90
100,00%
SUMMARY OF CLASSIFICATION
#r
Prevalence
ETF
0
0.000
LCF
1
0.016
LPF
4
0.063
ACPR
58
0.921
Total analysis
63
Withdrawal
13
LOSS
14
TOTAL
(ETF): Early Therapeutic Failure
(LCF ) Late Clinic Failure
(LPF Late Parasitological Failure)
ACPR) Adequate Clinical Response
90
0.3
Kaplan Meyer Analysis
Day
Number
of
patients
Failures
Loss +
Wth
Success
cumulative
incidence
Failure
cumulative
incidence
0
90
0
0
1.000
0.000
1
90
0
1
1.000
0.000
2
89
0
1
1.000
0.000
3
88
0
1
1.000
0.000
7
86
0
4
1.000
0.000
14
82
2
6
0.974
0.026
21
74
2
5
0.945
0.055
28
66
0
8
0.931
0.069
5
27
95 % CI
95 % CI
0.873
0.127
0.989
0.011
Total
Kaplan Meyer Analysis
Day
1
2
3
7
14
21
28
Gametocity density
Study 2004
Study 2007-2008
# Patients
%
# Patients %
24
33.8
2
2.27
24
33.8
37
41.57
20
28.2
35
40.23
18
25
21
25.30
12
8
1
16.9
11.3
1.4
11
5
2
14.29
6.76
2.90