Table.
Country | Study type | Study population | Comparators* | Efficacy data | SAE† | Deaths | DOT,‡number of courses | |
---|---|---|---|---|---|---|---|---|
Bigira, 201431 | Uganda | Clinical trial-IPT | Children under 5 years including HIV exposed infants | DP 98 SP 98 CTX 99 No treatment 98 |
Monthly active detection of parasitaemia from 6–24 months of age | DP 13 SP 52 CTX 29 No treatment 26 |
DP 0 SP 2 CTX 2 No treatment 1 |
First dose DOT, 1592 courses administered§ |
Bojang, 201032 | The Gambia | Clinical trial-IPT | Children under 5 years | DP 336 (335, 328) SP+AQ 336 SP+PQ 336 No treatment 286 |
Any malaria within 16-week rainy season (passive surveillance), active detection at study end | DP 4 SP+AQ 2 SP+PQ 1 No treatment 0 |
DP 1 SP+AQ 0 SP+PQ 0 No treatment 0 |
All doses DOT, 952 courses administered |
Cisse, 200933 | Senegal | Clinical trial-IPT | Children under 5 years | DP 598 (578, 539) SP+AQ 607 SP+PQ 654 |
Passive detection of malaria during 4-month rainy season, active detection at study end | DP 2 SP+AQ 2 SP+PQ 2 |
DP 2 SP+AQ 2 SP+PQ 2 |
First dose DOT, 1544 courses administered |
Desai, 201537 | Kenya | Clinical trial-IPT | Pregnant women in second or third trimester | IPT-DP 516 (516, 477) IST-DP 515 (167, 27) IPT-SP 515 |
Active detection of parasitaemia at each antenatal clinic visit during pregnancy | IPT-DP 37 IST-DP 82 IPT-SP 85 |
IPT-DP 0 IST-DP 1 IPT-SP 2 |
First dose DOT, 1585 courses administered |
Kakuru,201538 | Uganda | Clinical trial-IPT | Pregnant women in second or third trimester | DP monthly 100 DP ×3 94 SP ×3 106 |
Monthly assessment with LAMP¶ | DP monthly 4 DP ×3 9 SP ×3 6 |
DP monthly 0 DP ×3 0 SP ×3 0 |
First dose DOT, 1136 courses administered |
Kamya,201434 | Uganda | Clinical trial-IPT | Children under 5 years | DP 47 SP 46 CTX 47 No treatment 46 |
Monthly active detection of parasitaemia from age 4–5 months until age 24 months | DP 10 SP 23 CTX 16 No treatment 21 |
DP 1 SP 2 CTX 2 No treatment 2 |
No DOT, drug intake recorded by parents, 561 courses administered§ |
Lwin,201236 | Thailand | Clinical trial-IPT | Adults | DP 387 DP Q2month 381 Placebo 193 |
Monthly active detection of parasitaemia for 36 weeks | DP 1 DP Q2 month 0 Placebo 0 |
DP 1 DP Q2 month 0 Placebo 0 |
All doses DOT, 4089 courses administered§ |
Nankabirwa, 201435 | Uganda | Clinical trial-IPT | School-age children (aged 6–14 years) | DP 244 DP quarterly 248 Placebo 248 |
Monthly active detection of parasitaemia for 12 months | DP 6 DP quarterly 5 Placebo 2 |
DP 0 DP quarterly 1 Placebo 0 |
All doses DOT, 2648 courses administered |
Poespoprodjo, 201430 | Indonesia | Cohort study-treatment | Pregnant women in second or third trimester | DP 408 (408, 64) ‖ SP+CQ 24 Quinine 402 No treatment 4454 |
No | DP 10 SP+CQ 0 Quinine 18 No treatment 134 |
DP 0 SP+CQ 0 Quinine 0 No treatment 0 |
First dose DOT, 486 courses administered |
Wanzira, 201420 | Uganda | Clinical trial-treatment | Children under 5 years including HIV exposed infants | DP (+/− CTX) 154 (154, 147)** AL (+/− CTX) 158 |
Passive detection of parasitaemia before age 5 years | DP 13 DP+CTX 23 AL 39 AL+CTX 14 |
DP 0 DP+CTX 4 AL 1 AL+CTX 3 |
First dose DOT, 2218 courses administered |
Zongo, 20156 | Burkina Faso | Clinical trial-IPT | Children under 5 years | DP 750 (757)†† SP+AQ 749 (742)†† No treatment 250 |
Monthly active detection of parasitaemia for 4 months | DP 6 SP+AQ 3 No treatment 2 |
DP 4 SP+AQ 2 No treatment 1 |
All doses DOT, 2063 courses administered |
SAE=serious adverse event. DOT=directly observed therapy. IPT=intermittent preventive treatment. IST=intermittent screening and treatment. DP=dihydroartemisinin-piperaquine. SP=sulfadoxine pyrimethamine. CTX=co-trimoxazole. AQ=amodiaquine, PQ=piperaquine. CQ=chloroquine. AL=artemether-lumefantrine. Q2month=every other month. CHW=community health worker. LAMP=loop-mediated isothermal amplification.
Numbers in brackets represent the number who received one or more and two or more courses of DP, if reported to be different from the overall sample size in the DP group.
In addition to any other SAEs reported by the study, all hospital admissions and deaths were considered SAEs. SAEs were reported unrelated to study drugs unless otherwise noted: Bigira and colleagues reported 19 (4·5%) grade 3–4 AEs as possibly related to study drugs, with no significant differences between the intervention groups. Desai and colleagues reported one drug related SAE (an allergic reaction to DP); Kakuru and colleagues reported one patient who developed anaemia after both the first and second dose of DP, after which DP was stopped; Kamya and colleagues reported eight (5·6%) AEs possibly related to study drugs, with no significant differences between the intervention groups; Lwin and colleagues reported that four patients withdrew due to drug related AEs (two in the DP every other month group and two in placebo group).
DOT by study staff, first dose=only the first dose of each course was administered as DOT.
The total number of doses was divided by three to estimate the number of courses and rounded to the nearest whole number.
Reported prevalence over the course of pregnancy (incidence was not reported).
Average duration between courses 4·2 months
Average duration between courses 2·2 months
Intention to treat included 750 in the DP group and 740 in the SP+AQ group, but due to allocation errors, 757 were given DP and 742 were given SP+AQ.