Baseline Characteristics of Enrolled Patients According to Treatment Arma and Study Site
| . | Pailin, Cambodia . | Wang Pha, Thailand . | P Value . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Characteristic . | AS7 (n = 25) . | AS7_split (n = 25) . | 8MAS3(n = 14) . | 8MAS3_split (n = 15) . | AS7 (n = 20) . | AS7_split(n = 21) . | 8MAS3(n = 19) . | 8MAS3_split(n = 20) . | Pailin vsWang Pha . |
| Male sex, No. (%) | 23 (92) | 22 (88) | 11 (79) | 10 (67) | 19 (95) | 19 (90) | 18 (95) | 18 (90) | .08 |
| Age, y | .003 | ||||||||
| Mean (SD) | 28 (11) | 24 (9) | 24 (13) | 20 (8) | 28 (8) | 27 (6) | 29 (7) | 33 (12) | |
| Weight, kg | .18 | ||||||||
| Median | 53 | 51 | 46 | 49 | 52 | 52 | 51 | 52 | |
| IQR | 50–56 | 48–54 | 28–53 | 25–54 | 49–55 | 49–57 | 48–54 | 47–56 | |
| Temperature, °C | .0001 | ||||||||
| Mean (SD) | 38.4 (1.0) | 38.6 (1.0) | 38.5 (0.9) | 38.8 (1.0) | 38.1 (1.0) | 37.4 (0.6) | 37.5 (0.6) | 37.8 (0.8) | |
| Creatinine, mg/dL | .0017 | ||||||||
| Median | 1.00 | 1.00 | 0.80 | 0.90 | 1.10 | 1.00 | 1.00 | 1.00 | |
| IQR | 0.80–1.20 | 0.80–1.10 | 0.80–1.10 | 0.80–1.10 | 0.90–1.25 | 0.95–1.10 | 0.90–1.20 | 0.90–1.20 | |
| Alanine aminotransferase, U/L | .0001 | ||||||||
| Median | 23 | 24 | 21 | 22 | 14 | 11 | 17 | 18 | |
| IQR | 20–33 | 19–29 | 16–25 | 19–26 | 8–25 | 8–21 | 9–38 | 10–26 | |
| Alkaline phosphatase, U/L | .0004 | ||||||||
| Median | 74 | 91 | 105 | 105 | 69 | 60 | 70 | 81 | |
| IQR | 66–95 | 83–110 | 61–159 | 69–131 | 64–82 | 57–78 | 66–110 | 69–91 | |
| White cell count, ×10³/μL | .04 | ||||||||
| Median | 5.9 | 6.1 | 6 | 6.3 | 5.9 | 4.5 | 5.5 | 4.9 | |
| IQR | 4.8–7.2 | 5.1–7.7 | 5.2–6.7 | 5.2–8.2 | 3.9–8.3 | 3.4–7.0 | 5.0–7.3 | 3.8–6.9 | |
| Platelet count, ×10³/μL | .017 | ||||||||
| Median | 106 | 118 | 119 | 93 | 96 | 69 | 83 | 85 | |
| IQR | 85–131 | 96–140 | 68–173 | 75–133 | 64–128 | 54–145 | 61–153 | 51–120 | |
| Parasite density, parasites/μL | .18 | ||||||||
| Geometric mean | 54 539 | 52 237 | 47 356 | 58 393 | 32 507 | 36 244 | 58 294 | 42 541 | |
| 95% CI | 34 151–87 097 | 33 553–81 324 | 34 068–65 827 | 34 299–99 412 | 18 962–55 727 | 21 906–59 964 | 32 295–10 5225 | 27 240–66 437 | |
| Presence of gametocytes, No. (%) | 4 (16) | 5 (20) | 1 (7) | 3 (20) | 1 (5) | 3 (14) | 6 (32) | 7 (35) | .54 |
| . | Pailin, Cambodia . | Wang Pha, Thailand . | P Value . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Characteristic . | AS7 (n = 25) . | AS7_split (n = 25) . | 8MAS3(n = 14) . | 8MAS3_split (n = 15) . | AS7 (n = 20) . | AS7_split(n = 21) . | 8MAS3(n = 19) . | 8MAS3_split(n = 20) . | Pailin vsWang Pha . |
| Male sex, No. (%) | 23 (92) | 22 (88) | 11 (79) | 10 (67) | 19 (95) | 19 (90) | 18 (95) | 18 (90) | .08 |
| Age, y | .003 | ||||||||
| Mean (SD) | 28 (11) | 24 (9) | 24 (13) | 20 (8) | 28 (8) | 27 (6) | 29 (7) | 33 (12) | |
| Weight, kg | .18 | ||||||||
| Median | 53 | 51 | 46 | 49 | 52 | 52 | 51 | 52 | |
| IQR | 50–56 | 48–54 | 28–53 | 25–54 | 49–55 | 49–57 | 48–54 | 47–56 | |
| Temperature, °C | .0001 | ||||||||
| Mean (SD) | 38.4 (1.0) | 38.6 (1.0) | 38.5 (0.9) | 38.8 (1.0) | 38.1 (1.0) | 37.4 (0.6) | 37.5 (0.6) | 37.8 (0.8) | |
| Creatinine, mg/dL | .0017 | ||||||||
| Median | 1.00 | 1.00 | 0.80 | 0.90 | 1.10 | 1.00 | 1.00 | 1.00 | |
| IQR | 0.80–1.20 | 0.80–1.10 | 0.80–1.10 | 0.80–1.10 | 0.90–1.25 | 0.95–1.10 | 0.90–1.20 | 0.90–1.20 | |
| Alanine aminotransferase, U/L | .0001 | ||||||||
| Median | 23 | 24 | 21 | 22 | 14 | 11 | 17 | 18 | |
| IQR | 20–33 | 19–29 | 16–25 | 19–26 | 8–25 | 8–21 | 9–38 | 10–26 | |
| Alkaline phosphatase, U/L | .0004 | ||||||||
| Median | 74 | 91 | 105 | 105 | 69 | 60 | 70 | 81 | |
| IQR | 66–95 | 83–110 | 61–159 | 69–131 | 64–82 | 57–78 | 66–110 | 69–91 | |
| White cell count, ×10³/μL | .04 | ||||||||
| Median | 5.9 | 6.1 | 6 | 6.3 | 5.9 | 4.5 | 5.5 | 4.9 | |
| IQR | 4.8–7.2 | 5.1–7.7 | 5.2–6.7 | 5.2–8.2 | 3.9–8.3 | 3.4–7.0 | 5.0–7.3 | 3.8–6.9 | |
| Platelet count, ×10³/μL | .017 | ||||||||
| Median | 106 | 118 | 119 | 93 | 96 | 69 | 83 | 85 | |
| IQR | 85–131 | 96–140 | 68–173 | 75–133 | 64–128 | 54–145 | 61–153 | 51–120 | |
| Parasite density, parasites/μL | .18 | ||||||||
| Geometric mean | 54 539 | 52 237 | 47 356 | 58 393 | 32 507 | 36 244 | 58 294 | 42 541 | |
| 95% CI | 34 151–87 097 | 33 553–81 324 | 34 068–65 827 | 34 299–99 412 | 18 962–55 727 | 21 906–59 964 | 32 295–10 5225 | 27 240–66 437 | |
| Presence of gametocytes, No. (%) | 4 (16) | 5 (20) | 1 (7) | 3 (20) | 1 (5) | 3 (14) | 6 (32) | 7 (35) | .54 |
Abbreviations: CI, confidence interval; IQR, interquartile range; SD, standard deviation.
a Patients were randomly allocated to 1 of 4 treatment arms: (1) AS alone in a dose of 6 mg/kg/d for 7 days (AS7); (2) the same total dose, but given as a split twice-daily dose (AS7_split); (3) AS in a dose of 8 mg/kg/d for 3 days, followed by mefloquine in a dose of 15 mg/kg on day 3 and 10 mg/kg on day 4 (8MAS3); (4) the same total dose, but AS given as a split twice-daily dose (8MAS3_split). Arms AS7 and AS7_split were suspended after an association with neutropenia was reported in a separate study [12]. The 7-day regimens using AS 6 mg/kg/d were then replaced by 3 days of AS 6 mg/kg/d either as single or split daily dose, followed by mefloquine 25 mg/kg divided over 2 days.
Baseline Characteristics of Enrolled Patients According to Treatment Arma and Study Site
| . | Pailin, Cambodia . | Wang Pha, Thailand . | P Value . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Characteristic . | AS7 (n = 25) . | AS7_split (n = 25) . | 8MAS3(n = 14) . | 8MAS3_split (n = 15) . | AS7 (n = 20) . | AS7_split(n = 21) . | 8MAS3(n = 19) . | 8MAS3_split(n = 20) . | Pailin vsWang Pha . |
| Male sex, No. (%) | 23 (92) | 22 (88) | 11 (79) | 10 (67) | 19 (95) | 19 (90) | 18 (95) | 18 (90) | .08 |
| Age, y | .003 | ||||||||
| Mean (SD) | 28 (11) | 24 (9) | 24 (13) | 20 (8) | 28 (8) | 27 (6) | 29 (7) | 33 (12) | |
| Weight, kg | .18 | ||||||||
| Median | 53 | 51 | 46 | 49 | 52 | 52 | 51 | 52 | |
| IQR | 50–56 | 48–54 | 28–53 | 25–54 | 49–55 | 49–57 | 48–54 | 47–56 | |
| Temperature, °C | .0001 | ||||||||
| Mean (SD) | 38.4 (1.0) | 38.6 (1.0) | 38.5 (0.9) | 38.8 (1.0) | 38.1 (1.0) | 37.4 (0.6) | 37.5 (0.6) | 37.8 (0.8) | |
| Creatinine, mg/dL | .0017 | ||||||||
| Median | 1.00 | 1.00 | 0.80 | 0.90 | 1.10 | 1.00 | 1.00 | 1.00 | |
| IQR | 0.80–1.20 | 0.80–1.10 | 0.80–1.10 | 0.80–1.10 | 0.90–1.25 | 0.95–1.10 | 0.90–1.20 | 0.90–1.20 | |
| Alanine aminotransferase, U/L | .0001 | ||||||||
| Median | 23 | 24 | 21 | 22 | 14 | 11 | 17 | 18 | |
| IQR | 20–33 | 19–29 | 16–25 | 19–26 | 8–25 | 8–21 | 9–38 | 10–26 | |
| Alkaline phosphatase, U/L | .0004 | ||||||||
| Median | 74 | 91 | 105 | 105 | 69 | 60 | 70 | 81 | |
| IQR | 66–95 | 83–110 | 61–159 | 69–131 | 64–82 | 57–78 | 66–110 | 69–91 | |
| White cell count, ×10³/μL | .04 | ||||||||
| Median | 5.9 | 6.1 | 6 | 6.3 | 5.9 | 4.5 | 5.5 | 4.9 | |
| IQR | 4.8–7.2 | 5.1–7.7 | 5.2–6.7 | 5.2–8.2 | 3.9–8.3 | 3.4–7.0 | 5.0–7.3 | 3.8–6.9 | |
| Platelet count, ×10³/μL | .017 | ||||||||
| Median | 106 | 118 | 119 | 93 | 96 | 69 | 83 | 85 | |
| IQR | 85–131 | 96–140 | 68–173 | 75–133 | 64–128 | 54–145 | 61–153 | 51–120 | |
| Parasite density, parasites/μL | .18 | ||||||||
| Geometric mean | 54 539 | 52 237 | 47 356 | 58 393 | 32 507 | 36 244 | 58 294 | 42 541 | |
| 95% CI | 34 151–87 097 | 33 553–81 324 | 34 068–65 827 | 34 299–99 412 | 18 962–55 727 | 21 906–59 964 | 32 295–10 5225 | 27 240–66 437 | |
| Presence of gametocytes, No. (%) | 4 (16) | 5 (20) | 1 (7) | 3 (20) | 1 (5) | 3 (14) | 6 (32) | 7 (35) | .54 |
| . | Pailin, Cambodia . | Wang Pha, Thailand . | P Value . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Characteristic . | AS7 (n = 25) . | AS7_split (n = 25) . | 8MAS3(n = 14) . | 8MAS3_split (n = 15) . | AS7 (n = 20) . | AS7_split(n = 21) . | 8MAS3(n = 19) . | 8MAS3_split(n = 20) . | Pailin vsWang Pha . |
| Male sex, No. (%) | 23 (92) | 22 (88) | 11 (79) | 10 (67) | 19 (95) | 19 (90) | 18 (95) | 18 (90) | .08 |
| Age, y | .003 | ||||||||
| Mean (SD) | 28 (11) | 24 (9) | 24 (13) | 20 (8) | 28 (8) | 27 (6) | 29 (7) | 33 (12) | |
| Weight, kg | .18 | ||||||||
| Median | 53 | 51 | 46 | 49 | 52 | 52 | 51 | 52 | |
| IQR | 50–56 | 48–54 | 28–53 | 25–54 | 49–55 | 49–57 | 48–54 | 47–56 | |
| Temperature, °C | .0001 | ||||||||
| Mean (SD) | 38.4 (1.0) | 38.6 (1.0) | 38.5 (0.9) | 38.8 (1.0) | 38.1 (1.0) | 37.4 (0.6) | 37.5 (0.6) | 37.8 (0.8) | |
| Creatinine, mg/dL | .0017 | ||||||||
| Median | 1.00 | 1.00 | 0.80 | 0.90 | 1.10 | 1.00 | 1.00 | 1.00 | |
| IQR | 0.80–1.20 | 0.80–1.10 | 0.80–1.10 | 0.80–1.10 | 0.90–1.25 | 0.95–1.10 | 0.90–1.20 | 0.90–1.20 | |
| Alanine aminotransferase, U/L | .0001 | ||||||||
| Median | 23 | 24 | 21 | 22 | 14 | 11 | 17 | 18 | |
| IQR | 20–33 | 19–29 | 16–25 | 19–26 | 8–25 | 8–21 | 9–38 | 10–26 | |
| Alkaline phosphatase, U/L | .0004 | ||||||||
| Median | 74 | 91 | 105 | 105 | 69 | 60 | 70 | 81 | |
| IQR | 66–95 | 83–110 | 61–159 | 69–131 | 64–82 | 57–78 | 66–110 | 69–91 | |
| White cell count, ×10³/μL | .04 | ||||||||
| Median | 5.9 | 6.1 | 6 | 6.3 | 5.9 | 4.5 | 5.5 | 4.9 | |
| IQR | 4.8–7.2 | 5.1–7.7 | 5.2–6.7 | 5.2–8.2 | 3.9–8.3 | 3.4–7.0 | 5.0–7.3 | 3.8–6.9 | |
| Platelet count, ×10³/μL | .017 | ||||||||
| Median | 106 | 118 | 119 | 93 | 96 | 69 | 83 | 85 | |
| IQR | 85–131 | 96–140 | 68–173 | 75–133 | 64–128 | 54–145 | 61–153 | 51–120 | |
| Parasite density, parasites/μL | .18 | ||||||||
| Geometric mean | 54 539 | 52 237 | 47 356 | 58 393 | 32 507 | 36 244 | 58 294 | 42 541 | |
| 95% CI | 34 151–87 097 | 33 553–81 324 | 34 068–65 827 | 34 299–99 412 | 18 962–55 727 | 21 906–59 964 | 32 295–10 5225 | 27 240–66 437 | |
| Presence of gametocytes, No. (%) | 4 (16) | 5 (20) | 1 (7) | 3 (20) | 1 (5) | 3 (14) | 6 (32) | 7 (35) | .54 |
Abbreviations: CI, confidence interval; IQR, interquartile range; SD, standard deviation.
a Patients were randomly allocated to 1 of 4 treatment arms: (1) AS alone in a dose of 6 mg/kg/d for 7 days (AS7); (2) the same total dose, but given as a split twice-daily dose (AS7_split); (3) AS in a dose of 8 mg/kg/d for 3 days, followed by mefloquine in a dose of 15 mg/kg on day 3 and 10 mg/kg on day 4 (8MAS3); (4) the same total dose, but AS given as a split twice-daily dose (8MAS3_split). Arms AS7 and AS7_split were suspended after an association with neutropenia was reported in a separate study [12]. The 7-day regimens using AS 6 mg/kg/d were then replaced by 3 days of AS 6 mg/kg/d either as single or split daily dose, followed by mefloquine 25 mg/kg divided over 2 days.
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