Background
Patients and methods
Patients
Drug management
Laboratory investigations
Determination of gametocyte sex ratio
Data analysis
Results
Baseline characteristics of patients at enrolment
Year | |||||
---|---|---|---|---|---|
2000 | 2004 | 2006 | 2000–2006 | ||
Enrolled | N | 105 | 390 | 120 | 615 |
Gender | F/M | 53/52 | 195/195 | 70/50 | 318/297 |
Age (years) | Mean | 5.6 | 6.7 | 6.7 | 6.5 |
SD | 2.7 | 3.3 | 3.2 | 3.2 | |
Weight (kg) | Mean | 15.6 | 18.1 | 18.6 | 17.8 |
SD | 4.9 | 7.1 | 6.8 | 6.8 | |
Packed cell volume (%) | Mean | 29.8 | 30 | 31.2 | 30.3 |
SD | 3.9 | 3.9 | 3.9 | 3.9 | |
Duration of illness (days) | Mean | 2.9 | 2.9 | 2.9 | 2.9 |
SD | 1.2 | 1.2 | 1.1 | 1.2 | |
Temperature (°C) | Mean | 38.2 | 38.2 | 38.1 | 38.1 |
SD | 1.2 | 1.2 | 1.2 | 1.2 | |
Asexual parasitaemia (/μL) | GM | 21,261 | 21,468 | 68,839* | 26,908 |
Gametocytaemia (/μL) | GM | 13 | 15 | 17 | 15 |
Parasite clearance time (days) | Mean | 2.6 | 2.6 | 2.8 | 2.7 |
SD | 0.8 | 0.7 | 1.7 | 1.3 | |
Fever clearance time (days) | Mean | 1.1 | 1.1 | 1.1 | 1.1 |
SD | 0.4 | 0.4 | 0.3 | 0.4 |
Clinical responses
Parasitological responses
Gametocytaemia
Gametocyte carriage | |||||
---|---|---|---|---|---|
Year | No. | At enrolment | After treatment | Total | P value |
2000 | 104 | 12 (11.5) | 13 (12.5) | 25 | 1.0 |
2004 | 388 | 38 (9.8) | 29 (7.5) | 67 | 0.31 |
2006 | 120 | 16 (13.3) | 14 (11.7) | 30 | 0.85 |
2000–2006 | 612 | 66 (10.8) | 56 (9.2) | 122 | 0.39 |
Year | ||||||
---|---|---|---|---|---|---|
Days of follow up | Gametocyte density (/μL) | 2000 | 2004 | 2006 | 2000–2006 | P value |
0 | GM | 13 (12) | 16 (38) | 17 (16) | 16 (66) | 0.66 |
Range | 6 – 498 | 6 – 288 | 6 – 138 | 6 – 498 | ||
1 | GM | 13 (4) | 17 (37) | 24 (8) | 18 (49) | 0.85 |
Range | 6 – 48 | 6 – 648 | 6 – 114 | 6 – 648 | ||
2 | GM | 21 (7) | 20 (34) | 35 (6) | 21 (47) | 0.77 |
Range | 6 – 174 | 6 – 600 | 6 – 396 | 6 – 600 | ||
3 | GM | 18 (11) | 25 (38) | 19 (21) | 23 (70) | 0.75 |
Range | 6 – 210 | 6 – 720 | 6 – 798 | 6 – 798 | ||
7 | GM | 10 (12) | 32 (22) | 22 (16) | 22 (50) | 0.3 |
Range | 6 – 24 | 6 – 600 | 6 – 558 | 6 – 600 | ||
14 | GM | 11 (5) | 14 (16) | 11 (8) | 13 (29) | 0.7 |
Range | 6 – 18 | 6 – 108 | 6 – 180 | 6 – 180 | ||
21 | GM | - | 9 (4) | 18 (1) | 10 (5) | 0.36 |
Range | 6 – 12 | 18 | 6 – 18 | |||
28 | GM | - | 12 (2) | 57 (2) | 26 (4) | 0.82 |
Range | 12 | 6 – 546 | 6 – 546 |
Duration of gametocyte carriage in children with gametocytaemia at enrolment
Temporal changes in gametocyte sex ratio
Year | ||||||
---|---|---|---|---|---|---|
Days of follow up | Sex ratio | 2000 | 2004 | 2006 | 2000–2006 | P value |
0 | Mean | 0.004 (12) | 0.048 (38) | 0.2 (16) | 0.076 (66) | < 0.0001 |
SE | 0.004 | 0.019 | 0.05 | 0.019 | ||
1 | Mean | 0.0 (4) | 0.076 (37) | 0.32 (8) | 0.11 (49) | 0.003 |
SE | 0.0 | 0.025 | 0.12 | 0.03 | ||
2 | Mean | 0.13 (7) | 0.1 (34) | 0.25 (6) | 0.13 (47) | 0.3 |
SE | 0.08 | 0.03 | 0.08 | 0.03 | ||
3 | Mean | 0.29 (11) | 0.15 (38) | 0.4 (21) | 0.25 (70) | 0.006 |
SE | 0.1 | 0.03 | 0.08 | 0.04 | ||
7 | Mean | 0.25 (12) | 0.25 (22) | 0.37 (16) | 0.29 (50) | 0.48 |
SE | 0.11 | 0.05 | 0.1 | 0.05 | ||
14 | Mean | 0.13 (5) | 0.28 (18) | 0.51 (6) | 0.3 (29) | 0.14 |
SE | 0.08 | 0.08 | 0.14 | 0.06 | ||
21 | Mean | - | 0.25 (4) | 0.3 (1) | 0.26 (5) | - |
SE | - | 0.25 | - | 0.19 | ||
28 | Mean | - | 0.0 (2) | 0.52 (2) | 0.26 (4) | 0.46 |
SE | - | 0.0 | 0.19 | 0.17 |
Relationship between gametocyte sex ratio and gametocytaemia or asexual parasitaemia
Risk factors associated with a male-biased gametocyte sex ratio
Variables | Total Number | No with gsr ≥ 0.5 | OR (95% CI) | P value |
---|---|---|---|---|
Gender | ||||
male | 37 | 2 | 1 | |
female | 29 | 3 | 2 (0.4 – 9.8) | 0.45 |
Age | ||||
< 5 years | 29 | 1 | 1 | |
> 5 years | 37 | 4 | 3.4 (0.36 – 32) | 0.26 |
Duration of illness | ||||
≤ 3 days | 54 | 5 | 1 | |
≥ 3 days | 12 | 0 | 0.9 (0.8 – 1) | 0.16 |
Fever* | ||||
afebrile | 29 | 5 | 1 | |
febrile | 36 | 0 | 0.8 (0.7 – 1) | 0.01 |
Packed cell volume | ||||
≤ 25% | 11 | 3 | 1 | |
≥ 25% | 43 | 2 | 0.1 (0.02 – 0.9) | 0.02 |
Parasitaemia | ||||
≤ 20,000 μl/l | 33 | 0 | 1 | |
> 20,000 μl/l | 33 | 5 | 1.2 (1 – 1.4) | 0.02 |
Gametocytaemia | ||||
< 18 μl/l | 38 | 5 | 1 | |
≥ 18 μl/l | 28 | 0 | 0.8 (0.7 – 1) | 0.04 |
Year | ||||
Pre 2006 | 50 | 1 | 1 | |
2006 onwards | 16 | 4 | 16 (1.7 – 159.7) | 0.002 |
Variables | Total Number | No with gsr ≥ 0.5 | OR (95% CI) | P value | AOR (95% CI) | P value |
---|---|---|---|---|---|---|
Gender | ||||||
male | 25 | 7 | 1 | |||
female | 25 | 8 | 1.1 (0.6 – 2) | 0.75 | - | - |
Age | ||||||
< 5 years | 20 | 7 | 1 | |||
≥ 5 years | 30 | 8 | 0.8 (0.5 – 1.4) | 0.5 | - | - |
Duration of illness | ||||||
≤ 3 days | 38 | 12 | 1 | |||
> 3 days | 12 | 3 | 0.8 (0.2 – 2.5) | 0.67 | - | - |
Fever* | ||||||
afebrile | 21 | 6 | 1 | |||
febrile | 29 | 9 | 1.1 (0.6 – 1.7) | 0.85 | - | - |
PCV (day 0) | ||||||
< 25% | 6 | 5 | 1 | 1 | ||
≥ 25% | 44 | 10 | 0.6 (0.5 – 1) | 0.002 | 0.06 (0.006 – 0.7) | 0.03 |
Parasitaemia (day 0) | ||||||
≤ 20,000 μl/l | 22 | 3 | 1 | 1 | ||
> 20,000 μl/l | 28 | 12 | 1.8 (1.1 – 2.7) | 0.025 | 5.7 (1 – 33) | 0.05 |
Gametocytaemia (day 0) | ||||||
< 18 μl/l | 11 | 4 | 1 | |||
≥ 18 μl/l | 17 | 7 | 1.1 (0.6 – 2) | 0.8 | - | - |
Year | ||||||
pre 2006 | 34 | 8 | 1 | |||
2006 | 16 | 7 | 1.8 (0.8 – 4) | 0.15 | - | - |
GSR (day 0) | ||||||
< 0.5 | 26 | 10 | 1 | |||
≥ 0.5 | 2 | 1 | 1.5 (0.1 – 22) | 0.75 | - | - |
FCT | ||||||
< 2 days | 33 | 10 | 1 | |||
≥ 2 days | 2 | 1 | 2.2 (0.1 – 32) | 0.56 | - | - |
PCT | ||||||
< 3 days | 32 | 8 | 1 | |||
≥ 3 days | 18 | 7 | 1.5 (0.7 – 3.1) | 0.3 | - | - |
PCV (day 7) | ||||||
< 25% | 4 | 3 | 1 | 1 | ||
≥ 25% | 46 | 12 | 0.8 (0.6 – 3.7) | 0.04 | 0.06 (0.003 – 1) | 0.05 |
Re-parasitaemia | ||||||
Absent | 44 | 14 | 1 | |||
Present | 6 | 1 | 0.5 (0.06 – 3.7) | 0.45 | - | - |