Table 2 Characteristics of studies included in in vivo anti-malarial drug efficacy studies against clinical vivax malaria in Ethiopia, 1 January, 2000 to 31 March, 2021
Study ID | Study period | Altitude (malaria transmission) | Study design | Key characteristics | Study district/ region | Treatment option and dose | Sample size (enrolled) | Gender (Male/ Female) | Median age in year (range/IQR) | Age range (year) | Follow-up days | Completed follow-up (N) | Treatment outcomes | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
TF | ACPR (n) | Ex | P. f./ mixed | |||||||||||||||||
 < 5 | 5–14 |  > 14 | ETF | LTF | ||||||||||||||||
Abreha et al [30]a | November- December, 2014 | 1800- 1900 (low) | A randomized double-blind placebo-controlled | Patients with normal glucose-6-phosphate dehydrogenase status with symptomatic P. vivax mono-infection | Bishoftu and Batu Health Centers, Oromia | CQb (25 mg/ Kg) | n = 104, Bishoftu (79), Batu (25), | 61.5% (n = 64) males, 38.5% (n = 40) females | 18 (IQR 10.5–19) | 7 | 31 | 66 | 42 | 96 | D28 | 1 | 3 | 92 | 2 | 2 |
91 | D42 | 1 | 17 | 77 | 7 | 2 | ||||||||||||||
CQ (25 mg/ Kg) and PQ (0.25 mg/kg) | n = 100 Bishoftu (73), Batu (27), | 70% (n = 70) males, 30% (n = 30) females | 18 ( IQR 10–26)* | 12 | 31 | 57 | 42 | 91 | D28 | 0 | 0 | 91 | 3 | 3 | ||||||
86 | D42 | 0 | 0 | 85 | 12 | 4 | ||||||||||||||
ALc | n = 102 Bishoftu (79), Batu (23) | 66.7% (n = 68) males, 33.3% (n = 34) females | 17 ( IQR 9–25)* | 10 | 37 | 55 | 42 | 92 | D28 | 0 | 11 | 81 | 0 | 0 | ||||||
90 | D42 | 0 | 27 | 62 | 11 | 0 | ||||||||||||||
AL and PQd (0.25 mg/kg) | n = 92, Bishoftu (76), Batu (16) | 55.4% (n = 50) males, 44.6% (n = 42) females | 18 ( IQR 9–27)* | 8 | 28 | 56 | 42 | 86 | D28 | 0 | 2 | 84 | 0 | 0 | ||||||
82 | D42 | 0 | 5 | 77 | 10 | 0 | ||||||||||||||
Assefa et al. [26] | April to June, 2014 | 2177 (low) | A single arm open-label prospective cohort trial | Patients with P. vivax infection, who fulfilled the WHO inclusion criteria | Hossana Health Centre, Hadiya Zone, SNNPR | CQ (25 mg/ Kg) | n = 63 | 58.3% (n = 35) males, 41.7% (n = 25) females | 23 median ( 4–59) | ND | ND | ND | 28 | 60 | 0 | 2 | 58 | 3 | 1 | |
Beyene et al. [24] | 17 August to 19 December, 2014 | 1450 (moderate) | A single arm open-label, prospective cohort trial | Patients visiting a health centre and presented with clinically suspected malaria | Bullen Health Centre Metekel zone, Benshangul | CQ (25 mg/ Kg) | n = 76 | 68% (n = 47) males, 32% (n = 22) females | 19 median (3–54) | 20 | 15 | 34 | 28 | 69 | 0 | 2 | 67 | 3 | 2 | |
Getachew et al [38] | May 2010 and December 2013 | Moderate | A single arm open-label, prospective cohort trial | Patients attending outpatient clinics with signs and symptoms consistent with malaria, who fulfilled the WHO inclusion criteria | Shele in Arba Minch, Guba in Halaba, Batu in Adami Tulu and Shone in Eastern Badawacho Districts | CQ (25 mg/ Kg) | Shele (89) | 65.2% (58) males, 34.8% (= 31) female) | 10 (IQR, 4–18) | 31 | 26 | 32 | 28 | 236 | 2 | 23 | 229 | 29 | 5 | |
Guba (52) | 57.7% (n = 30) males, 42.3% (n = 22) females | 12 (IQR, 4.5–22.5) | 16 | 18 | 18 | |||||||||||||||
Batu (n = 57) | 40.3% (n = 23) males, 59.3% (n = 34) females | 12 (IQR, 6–20) | 13 | 24 | 20 | |||||||||||||||
Shone (n = 90) | 56.7% (n = 51) males, 43.3% (n = 39) females | 6 (IQR, 4–9) | 43 | 33 | 14 | |||||||||||||||
Hwang et al. [25] 1 | October, 2009-January, 2010 | 1900 (low) | A randomized but open label cohort study | Patients with P. vivax mono-infection, who fulfilled the WHO inclusion criteria | Bishoftu and Bulbula Health Centers/Oromia | CQ (25 mg/Kg) | n = 120 | 68.3% (n = 82) males, 31.7% (n = 38) females | 18 median (1–65) | ND | ND | ND | 42 | 108 | D28 | 0 | 10 | 98 | 8 | ND |
107 | D42 | NA | 34 | 73 | 9 | ND | ||||||||||||||
AL | n = 122 | 62.3% (n = 76) males, 37.7% (n = 46) females | 11½ median (1–70) | ND | ND | ND | 42 | 115 | D28 | 0 | 28 | 86 | 12 | ND | ||||||
113 | D42 | NA | 47 | 66 | 13 | ND | ||||||||||||||
Kanche et al. [39] | 10 February to 09 May, 2011 | 1780 (low) | A single arm open-label prospective cohort trial | Suspected malaria patients seeking medication who fulfilled the WHO inclusion criteria | Jimma town/Ormia | CQ (25 mg/ Kg) | n = 81 | 50.6% (n = 41) males, 49.4% (n = 40) females | 6 months-60 years | 7 | 25 | 49 | 28 | 74 | 1 | 1 | 74 | 7 | ND | |
Ketema et al. [31] | October, 2007-January, 2008 | 1740 – 2660 (low) | A single arm open-label prospective cohort trial | Suspected malaria patients seeking medication, who fulfilled the WHO inclusion criteria | Serbo Health Center, Jimma zone, Oromia | CQ (25 mg/ Kg) | n = 84 | 60.7% (n = 51) males, 39.3%(n = 33) females | 8 median (9/12–45) | ND | ND | 21 | 28 | 78 | 0 | 3 | 78 | 2 | 3 | |
Ketema et al. [23] | January to February, 2009 | 1726 (moderate) | A single arm open-label prospective cohort trial | Individuals seeking treatment for malaria at a Health Center during the study period and having P. vivax mono-infection | Halaba Kulito Health Center/ Halaba town/ SNPPR | CQ (25 mg/ Kg) | n = 87 | 42.6% (n = 36) males, 57.4% (n = 51) females | 8 median (range 9/12–52) | 35 | 13 | 39 | 28 | 80 | 4 | 7 | 69 | 7 | 1 | |
Teka et al. [22] | June–August 2006 | 1900 (low) | A single arm open-label prospective cohort trial | Patients were recruited according to the WHO protocol for monitoring anti-malarial drug resistance | Bishoftu/Oromia | CQ (25 mg/ Kg) | n = 87 | 58.8% (n = 51) males, 41.4% (n = 36) females | 16 median (8/12- 52) | 18 | ND | ND | 28 | 83 | 0 | 4 | 79 | 1 | 3 | |
Seifu et al. [40] | October 2013 to February 2014 | 1280 (moderate) | A single arm open-label prospective cohort trial | The study participants were individuals who had confirmed P. vivax mono-infection and who fulfilled the WHO inclusion criteria | Shawa Robit Health Centre,/ Amhara | CQ (25 mg/ Kg) | n = 87 | 71.3% (n = 62) males, 28.7% (n = 25) females | 20 median (1–65) | 29 (< 15 years) | ND | 58 | 28 | 76 | 0 | 5 | 71 | 11 | 4 | |
Shumbej et al. [27] | December, 2016—May, 2017 | 1710–1950 (low) | A single-arm open-label, prospective cohort trial | P.vivax mono-infected patients, fulfilled the inclusion criteria | Gurage zone/SNNPR | CQ (25 mg/ Kg) | n = 87 | 54.3%, (n = 45) males, 45.7% (n = 37) females | 19 median (1.5–42) | 10 | 16 | 55 | 28 | 81 | 0 | 2 | 81 | 5 | 1 | |
Yeshanew et al. [41] | March and December, 2018 | 1700– 1900 (low) | A single-arm open-label, prospective cohort trial | Patients who were attending the outpatient clinics | Darimu District/ Oromia | CQ (25 mg/ Kg) | n = 128 | 64.5% (n = 42) males, 35.4% (n = 23) females | 20 median (2–71) | 3 | 24 (5–18 years) | 38(> 18 years) | 28 | 65 | 0 | 0 | ND | ND | ND | |
1300–1646 (moderate) | Bure District/ Oromia | CQ (25 mg/ Kg) |  | 70% (n = 35) males, 30% (n = 15) females | 23 median (5–60) | 1 | 9 (5–18 years) | 40 (> 18 years) | 28 | 50 | 0 | 0 | ND | ND | ND | |||||
Yeshiwondim et al. [28]1 | January-August, 2003 | 1900 (low) | A randomized, open-label, cohort study | Patients with slide-confirmed malaria who presented to the outpatient settings | Debrezeit/Bishoftu and Nazareth/Adama towns/ Oromia | CQ (25 mg/ Kg) | n = 145 | 53.7% (n = 78) males, 46.2% (n = 67) females | 20 median (4–65) | 2 | 34 | 109 | 28 | 141 | 0 | 4 | 136 | 10 | 3 | |
1622 (moderate) | CQ (25 mg/ Kg) and PQ (0.25 mg/kg) | n = 145 | 54.5% (n = 79) males, 45.5% (n = 66) females | 20 median (4–60) | 1 | 34 | 110 | 28 | 141 | 1 | 0 | 141 | 11 | 3 | ||||||
Yohannes et al. [29]a | October 2004 to May 2005 | 1900 (low) | A randomized, open-label, cohort study | Patients fulfilled the inclusion criteria of WHO protocol for monitoring anti-malarial drug resistance | Bishoftu/Oromia | CQ (25 mg/ Kg) | n = 27 | 55.6% (n = 15) males, 44.4% (n = 12) females | 21 median (IQR) (9.5–30) | 0 | ND | ND | 28 | 21 | 0 | 3 | 18 | 6 | ND | |
AL | n = 36 | 50% (n = 18) males, 50% (n = 18) females | 17 median (IQR) (10–25) | 2 | ND | ND | 28 | 30 | 0 | 7 | 23 | 6 | ND | |||||||
1622 (moderate) | Nazareth/Adama town | CQ (25 mg/ Kg) | n = 44 | 43.2% (n = 19) males, 56.8% (n = 25) females | 17.5 median (IQR) (13–25) | 5 | ND | ND | 28 | 36 | 0 | 2 | 34 | 8 | ND | |||||
AL | n = 52 | 40.4% (n = 21) males, 59.6% (n = 31) females | 17 median (IQR) (7.6–23.3) | 7 | ND | ND | 28 | 45 | 1 | 11 | 33 | 7 | ND | |||||||