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. 2017 Feb;17(2):184–193. doi: 10.1016/S1473-3099(16)30378-4

Table.

Details of included studies

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.