Table 2. Baseline characteristics of patients with uncomplicated P. falciparum malaria enrolled in the Phase I/II study of sevuparin (TSM02)*.
| Controls | Sevuparin | Total | |||
|---|---|---|---|---|---|
| (N = 23) | (N = 21) | (N = 44) | p-value | ||
| Age | Mean (SD) | 30.95 (9.78) | 29.19 (8.08) | 30.11 (8.95) | 0.520 |
| Median | 34.00 | 27.00 | 28.88 | ||
| Range | 18 to 51 | 19 to 42 | 18 to 51 | ||
| Sex, ratio female:male | Ratio | 01:22 | 04:17 | 05:39 | 0.176 |
| Body temperature (°C) | Mean (SD) | 37.43 (0.99) | 37.53 (0.98) | 37.48 (0.97) | 0.689 |
| Median | 37 | 37.6 | 37.25 | ||
| Range | 35.8 to 39.9 | 36 to 39.9 | 35.8 to 39.9 | ||
| Serum lactate dehydrogenase (U/L)** | Mean (SD) | 175.74 (52.43) | 170.48 (56.33) | 173.23 (53.75) | 0.681 |
| Median | 188 | 159 | 161.5 | ||
| Range | 91 to 283 | 90 to 310 | 90 to 310 | ||
| Serum glucose (mg/dL)*** | Mean (SD) | 126.50 (35.26) | 129.86 (31.45) | 128.14 (33.10) | 0.552 |
| Median | 119 | 128 | 121 | ||
| Range | 75 to 215 | 76 to 195 | 75 to 215 | ||
| ABO blood group | 0.308 | ||||
| A | N (%) | 8 (34.78) | 9 (42.86) | 17 (38.64) | |
| AB | N (%) | 2 (8.70) | 0 (0.00) | 2 (4.55) | |
| B | N (%) | 5 (21.74) | 8 (38.10) | 13 (29.55) | |
| O | N (%) | 8 (34.78) | 4 (19.05) | 12 (27.27) | |
| Parasitemia | Mean (SD) | 42107.04 (38719.56) |
36305.48 (35464.94) |
39338.11 (36886.76) |
0.499 |
| Median | 24390 | 20161 | 20629.5 | ||
| Range | 4956–121240 | 350–99750 | 350–121240 | ||
| Parasite stages (%): trophozoites, schizonts | Mean (SD) | 31.96 (35.67) | 28.33 (29.17) | 30.23 (32.41) | 0.981 |
| Median | 18 | 26 | 19.0 | ||
| Range | 0–100 | 0–97 | 0–100 | ||
| Parasite stages (%): rings | Mean (SD) | 68.00 (35.68) | 71.57 (29.14) | 69.70 (32.39) | 0.999 |
| Median | 82 | 74 | 80.5 | ||
| Range | 0–100 | 3–100 | 0–100 |
*Patients were treated with oral atovaquone/proguanil, without (controls) or with sevuparin (sevuparin) as adjunctive treatment in the form of short i.v. infusions. For details of the study (TSM02) please see Methods.
** (normal range: 114–240 U/L).
*** (normal range: 70–110).