S. no. | Author, Publication year | Study design | Study setting and period | Follow up | Subjects | Patient important outcome | DHA–PQ | AL | ||
---|---|---|---|---|---|---|---|---|---|---|
Number of participants | Inclusion age | |||||||||
DHA–PQ | AL | |||||||||
1 | Kamya, 2007 [39] | Single blind RCT | Rural health center, March, 2006–July, 2006 | 42 days | 253 | 256 | 6 months–10 years | Loss to follow up | 0 | 0 |
ETF | 0 | 0 | ||||||||
LCF | 19 | 30 | ||||||||
LPF | 73 | 89 | ||||||||
ACPR | 117 | 89 | ||||||||
Fever clearance at day 1 | 137 | 137 | ||||||||
Fever clearance at day 2 | 66 | 72 | ||||||||
Fever clearance at day 3 | 52 | 57 | ||||||||
Parasite clearance at day 2 | 1 | 2 | ||||||||
Parasite clearance at day 3 | 0 | 0 | ||||||||
Gametocyte carriage at baseline | 9 | 18 | ||||||||
Gametocyte carriage day 1–14 | 5 | 2 | ||||||||
Gametocyte carriage at day 15–28 | 0 | 5 | ||||||||
Gametocyte carriage at day 29–41 | 4 | 11 | ||||||||
Hgb at baseline mean (SD) | 9.5 (1.8) | 9.7 (1.9) | ||||||||
Hgb g/dL at day 42 mean (SD)a | 1.9 (1.8) | 1.5 (1.8) | ||||||||
Vomiting | 65 | 65 | ||||||||
Diarrhea | 25 | 19 | ||||||||
Anorexia | 90 | 91 | ||||||||
Abdominal pain | 19 | 20 | ||||||||
Weakness/malaise | 85 | 103 | ||||||||
Cough | 136 | 133 | ||||||||
Coryza | 127 | 121 | ||||||||
Pruritus | 14 | 22 | ||||||||
SAE | 4 | 2 | ||||||||
2 | Yeka, 2008 [40] | Single-blind RCT | Health center, August 2006–April 2007 | 42 days | 234 | 227 | 6 months–10 years | Los to follow up | 3 | 3 |
ETF | 0 | 1 | ||||||||
LCF | 9 | 23 | ||||||||
LPF | 17 | 41 | ||||||||
ACPR | 186 | 131 | ||||||||
Fever clearance at day 1 | 117 | 133 | ||||||||
Fever clearance at day 2 | 44 | 37 | ||||||||
Fever clearance at day 3 | 22 | 22 | ||||||||
Parasite clearance at day 2 | 7 | 5 | ||||||||
Parasite clearance at day 3 | 0 | 0 | ||||||||
Gametocyte carriage at baseline | 12 | 18 | ||||||||
Gametocyte carriage day 1–14 | 4 | 1 | ||||||||
Gametocyte carriage at day 15–28 | 1 | 7 | ||||||||
Gametocyte carriage at day 29–41 | 4 | 13 | ||||||||
Hgb at baseline mean (SD) | 9.9 (2.1) | 9.9 (1.8) | ||||||||
Hgb at day 42 mean (SD)a | 1.8 (1.8) | 1.7 (2.0) | ||||||||
Vomiting | 35 | 35 | ||||||||
Diarrhea | 26 | 23 | ||||||||
Anorexia | 47 | 49 | ||||||||
Abdominal pain | 17 | 24 | ||||||||
Weakness/malaise | 28 | 27 | ||||||||
Cough | 164 | 150 | ||||||||
Coryza | 159 | 150 | ||||||||
Pruritus | 8 | 3 | ||||||||
SAE | 5 | 2 | ||||||||
3 | Arinaitwe, 2009 [35] | Open-label RCT | Local antenatal clinics in Tororo, August 2007–July 2008 | 63 days | 119 | 111 | 6 weeks–12 months | Other anti-malaria use | 1 | 2 |
Loss to follow up | 5 | 2 | ||||||||
Complicated malaria at day 0 | 0 | 1 | ||||||||
Recurrent malaria caused by non-falciparum species | 0 | 1 | ||||||||
ETF | 0 | 0 | ||||||||
LCF | 13 | 45 | ||||||||
LPF | 26 | 64 | ||||||||
ACPR | 306 | 205 | ||||||||
Fever clearance at day 1 | 138 | 163 | ||||||||
Fever clearance at day 2 | 13 | 17 | ||||||||
Fever clearance at day 3 | 9 | 12 | ||||||||
Parasite clearance at day 2 | 12 | 22 | ||||||||
Parasite clearance at day 3 | 1 | 0 | ||||||||
Gametocyte carriage at baseline | 30 | 26 | ||||||||
Gametocyte carriage day 1–14 | 10 | 1 | ||||||||
Gametocyte carriage at day 15–28 | 1 | 0 | ||||||||
Hgb at baseline mean (SD) | 9.9 (1.5) | 9.8 (1.5) | ||||||||
Hgb at day 28 mean (SD)a | 0.6 (1.68) | 0.6 (1.56) | ||||||||
Vomiting | 23 | 20 | ||||||||
Diarrhea | 79 | 86 | ||||||||
Anorexia | 3 | 0 | ||||||||
Weakness | 1 | 0 | ||||||||
Cough | 177 | 153 | ||||||||
Pruritus | 0 | 0 | ||||||||
SAE | 3 | 1 | ||||||||
4 | Bassat, 2009 [76] | Open-label RCT (non-inferiority) | Rural sites and one peri-urban site, August 2005–July 2006 | 42 days | 164 | 82 | 6–59 months | PCR-corrected ACPR day 28 | 155 | 77 |
PCR-corrected ACPCR day 42 | 154 | 77 | ||||||||
5 | Katrak, 2009 [42] | Open-label RCT | N/A, August, 2007–April, 2008 | N/A | 124 | 122 | 6 weeks–12 months | Vomiting | 19 | 9 |
Diarrhea | 64 | 76 | ||||||||
Cough | 200 | 164 | ||||||||
SAE | 3 | 2 | ||||||||
6 | 4ABC, 2011 [36] | Open-label RCT | N/A, July 2007–June 2009 | 63 days | 422 | 421 | 6–59 months | Day 28 PCR-unadjusted ACPR | 360 | 313 |
Day 28 PCR-adjusted ACPR | 407 | 393 | ||||||||
Day 63 PCR-unadjusted ACPR | 234 | 209 | ||||||||
Day 63 PCR-adjusted ACPR | 375 | 371 | ||||||||
7 | Yeka, 2013 [37] | Single-blind RCT | Health center, December, 2007–April, 2009 | 28 days | 72 | 35 | 6–59 months | LTF | 0 | 0 |
ETF | 0 | 0 | ||||||||
LCF | 6 | 7 | ||||||||
LPF | 12 | 14 | ||||||||
ACPR | 54 | 14 | ||||||||
Fever clearance at day 1 | 48 | 14 | ||||||||
Fever clearance at day 2 | 15 | 21 | ||||||||
Fever clearance at day 3 | 4 | 2 | ||||||||
Parasite clearance at day 2 | 2 | 5 | ||||||||
Parasite clearance at day 3 | 0 | 0 | ||||||||
Gametocyte carriage at baseline | 0 | 0 | ||||||||
Gametocyte carriage day 1–14 | 0 | 0 | ||||||||
Gametocyte carriage at day 15–28 | 0 | 0 | ||||||||
Hgb at baseline mean (SD) | 10.8 (1.34) | 10.6 (1.41) | ||||||||
Hgb at day 28 mean (SD)a | 0.8 (1.7) | 0.9 (1.7) | ||||||||
Vomiting | 3 | 2 | ||||||||
Diarrhea | 1 | 2 | ||||||||
Anorexia | 12 | 3 | ||||||||
Abdominal pain | 5 | 0 | ||||||||
Weakness/malaise | 1 | 0 | ||||||||
Cough | 47 | 20 | ||||||||
SAE | 0 | 0 | ||||||||
8 | Kakuru, 2014 [77] | RCT | District Hospital, August 2007 and April 2008 | N/A | 21 | 22 | 6 weeks–12 months | Loss to follow up | 2 | 2 |
ETF | 0 | 0 | ||||||||
LCF | 3 | 19 | ||||||||
LPF | 11 | 53 | ||||||||
ACPR | 149 | 127 | ||||||||
Fever clearance at day 1 | 46 | 106 | ||||||||
Fever clearance at day 2 | 7 | 16 | ||||||||
Fever clearance at day 3 | 5 | 3 | ||||||||
Parasite clearance at day 2 | 5 | 32 | ||||||||
Parasite clearance at day 3 | 1 | 3 | ||||||||
Gametocyte carriage at baseline | 15 | 9 | ||||||||
Gametocyte carriage at day 15–28 | 30 | 15 | ||||||||
Hgb at baseline mean (SD) | 9.6 (1.5) | 10.1 (1.4) | ||||||||
Hgb at day 28 mean (SD)a | 1.0 (1.4) | 0.6 (1.5) | ||||||||
Vomiting | 8 | 18 | ||||||||
Diarrhea | 27 | 23 | ||||||||
Anorexia | 6 | 4 | ||||||||
Weakness/malaise | 2 | 2 | ||||||||
Cough | 64 | 74 | ||||||||
9 | Muhindo, 2014 [30] | Open-label, RCT | October District Hospital, October 2011–December, 2012 | 28 days | 106 | 96 | 6 weeks–12 months | 16 | ||
Loss to follow up | 13 | |||||||||
ETF | 1 | 0 | ||||||||
LCF | 7 | 74 | ||||||||
LPF | 22 | 137 | ||||||||
ACPR | 311 | 189 | ||||||||
Fever clearance at day 1 | 65 | 124 | ||||||||
Fever clearance at day 2 | 11 | 8 | ||||||||
Fever clearance at day 3 | 7 | 7 | ||||||||
Parasite clearance at day 1 | 181 | 269 | ||||||||
Parasite clearance at day 2 | 20 | 23 | ||||||||
Parasite clearance at day 3 | 1 | 0 | ||||||||
Hgb at baseline mean (SD) | 11.2 (1.5) | 11.1 (1.5) | ||||||||
10 | Wanzira, 2014 [38] | Open-label, RCT | District Hospital, February 2009–2012 | 28 days | 154 | 158 | 4 weeks–12 months | Other anti-malaria use | 3 | 5 |
Loss to follow up | 21 | 19 | ||||||||
Withdrawn consent | 1 | 2 | ||||||||
ETF | 2 | 15 | ||||||||
LCF | 48 | 475 | ||||||||
LPF | 182 | 894 | ||||||||
ACPR | 2403 | 1494 | ||||||||
11 | Yeka, 2019 [41] | Single-blind RCT | Health center and Hospital, October 2015–December, 2016 | 42 days | 299 | 300 | 6–59 months | No outcome | 11 | 10 |
ETF | 0 | 0 | ||||||||
LCF | 32 | 50 | ||||||||
LPF | 43 | 85 | ||||||||
ACPR | 213 | 155 | ||||||||
Fever clearance at day 1 | 208 | 231 | ||||||||
Fever clearance at day 2 | 71 | 72 | ||||||||
Fever clearance at day 3 | 31 | 18 | ||||||||
Parasite clearance at day 1 | 219 | 245 | ||||||||
Parasite clearance at day 2 | 22 | 34 | ||||||||
Parasite clearance at day 3 | 3 | 3 | ||||||||
Gametocyte carriage at baseline | 59 | 60 | ||||||||
Gametocyte carriage at day 1–42 | 43 | 46 | ||||||||
Hgb at day 42 mean (SD)a | 1.3 (1.69) | 0.8 (1.8) | ||||||||
Vomiting | 56 | 61 | ||||||||
Diarrhea | 155 | 114 | ||||||||
Anorexia | 12 | 3 | ||||||||
Abdominal pain | 41 | 45 | ||||||||
Headaches | 18 | 24 | ||||||||
Weakness/malaise | 42 | 33 | ||||||||
Cough | 233 | 203 | ||||||||
Pallor | 22 | 13 | ||||||||
Skin rash | 56 | 42 | ||||||||
Pruritus | 24 | 16 | ||||||||
SAE | 6 | 6 |