Monitoring of the Sensitivity In Vivo of Plasmodium falciparum to Artemether-Lumefantrine in Mali
Abstract
:1. Introduction
2. Materials and Methods
3. Results
3.1. Participant Flow
3.2. Baseline Data
3.3. Efficacy
3.4. Tolerability and Safety
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A
ID Patient | Visit Days | Study Sites | Pfmsp2 | PfCA1 | PfTA99 | Outcome |
---|---|---|---|---|---|---|
Season 2017, Total: 14 | ||||||
BOS006 | D0 | Bougouni | A | 1 | ||
BOS006 | D21 | Bougouni | B | |||
BOS009 | D0 | Bougouni | B | 1 | ||
BOS009 | D28 | Bougouni | AC | |||
BOS017 | D0 | Bougouni | A | 1 | ||
BOS017 | D28 | Bougouni | B | |||
BOS051 | D0 | Bougouni | A | 1 | ||
BOS051 | D28 | Bougouni | BC | |||
BAD052 | D0 | Bandiagara | B | 1 | ||
BAD052 | UV | Bandiagara | A | |||
BAD049 | D0 | Bandiagara | A | 1 | ||
BAD049 | D21 | Bandiagara | B | |||
BOS059 | D0 | Bougouni | A | 1 | ||
BOS059 | D28 | Bougouni | B | |||
BOS075 | D0 | Bougouni | A | 1 | ||
BOS075 | D21 | Bougouni | B | |||
BOS085 | D0 | Bougouni | A | C | 1 | |
BOS085 | D28 | Bougouni | A | AB | ||
BOS109 | D0 | Bougouni | A | A | 1 | |
BOS109 | D28 | Bougouni | A | B | ||
BOS114 | D0 | Bougouni | A | 1 | ||
BOS114 | D28 | Bougouni | B | |||
BOS115 | D0 | Bougouni | AB | 1 | ||
BOS115 | D21 | Bougouni | CD | |||
BOS129 | D0 | Bougouni | A | 1 | ||
BOS129 | D21 | Bougouni | B | |||
BOS163 | D0 | Bougouni | AB | AB | 1 | |
BOS163 | D21 | Bougouni | A | C | ||
Season 2018, Total: 39 | ||||||
BOK001 | D0 | Bougouni | A | B | 1 | |
BOK001 | D28 | Bougouni | 9 | A | ||
BOK002 | D0 | Bougouni | AC | A | 1 | |
BOK002 | D21 | Bougouni | AB | B | ||
BOK003 | D0 | Bougouni | A | A | 1 | |
BOK003 | D21 | Bougouni | BC | B | ||
BOK009 | D0 | Bougouni | AB | A | 1 | |
BOK009 | D28 | Bougouni | B | B | ||
BOK013 | D0 | Bougouni | AB | A | 1 | |
BOK013 | D21 | Bougouni | 9 | B | ||
BOK016 | D0 | Bougouni | A | A | 1 | |
BOK016 | D28 | Bougouni | 9 | B | ||
BOK019 | D0 | Bougouni | A | 1 | ||
BOK019 | D28 | Bougouni | B | |||
BOK020 | D0 | Bougouni | AB | B | 1 | |
BOK020 | D28 | Bougouni | B | A | ||
BOK024 | D0 | Bougouni | A | A | 1 | |
BOK024 | D28 | Bougouni | 9 | B | ||
BOK025 | D0 | Bougouni | A | B | 1 | |
BOK025 | D28 | Bougouni | A | A | ||
BOK026 | D0 | Bougouni | A | B | 1 | |
BOK026 | D28 | Bougouni | B | A | ||
BOK028 | D0 | Bougouni | 9 | A | 1 | |
BOK028 | D28 | Bougouni | A | B | ||
BOK030 | D0 | Bougouni | B | 1 | ||
BOK030 | D21 | Bougouni | A | |||
BOK031 | D0 | Bougouni | BD | AC | 1 | |
BOK031 | D21 | Bougouni | AC | B | ||
BOK038 | D0 | Bougouni | B | A | A | 1 |
BOK038 | D21 | Bougouni | ABC | 9 | B | |
BOK044 | D0 | Bougouni | B | 1 | ||
BOK044 | D28 | Bougouni | A | |||
BOK048 | D0 | Bougouni | AB | 9 | A | 1 |
BOK048 | D28 | Bougouni | A | A | B | |
BOK050 | D0 | Bougouni | AB | A | 1 | |
BOK050 | D21 | Bougouni | C | B | ||
BOK053 | D0 | Bougouni | A | A | AC | 1 |
BOK053 | D14 | Bougouni | 9 | A | B | |
BOK058 | D0 | Bougouni | A | 1 | ||
BOK058 | D28 | Bougouni | B | |||
BOK059 | D0 | Bougouni | A | A | A | 1 |
BOK059 | D28 | Bougouni | A | B | B | |
BOK060 | D0 | Bougouni | ACD | A | 1 | |
BOK060 | D28 | Bougouni | AB | B | ||
BOK062 | D0 | Bougouni | ABD | 1 | ||
BOK062 | D28 | Bougouni | C | |||
BOO003 | D0 | Bougouni | AD | A | 1 | |
BOO003 | D21 | Bougouni | AB | B | ||
BOO029 | D0 | Bougouni | AC | B | 1 | |
BOO029 | D21 | Bougouni | B | A | ||
BOO018 | D0 | Bougouni | ABD | A | 1 | |
BOO018 | D28 | Bougouni | 9 | B | ||
BOO019 | D0 | Bougouni | C | 1 | ||
BOO019 | D28 | Bougouni | AB | |||
BOO025 | D0 | Bougouni | AB | B | 1 | |
BOO025 | D28 | Bougouni | A | A | ||
BOO052 | D0 | Bougouni | AB | A | AC | 1 |
BOO052 | D28 | Bougouni | 9 | A | B | |
BOO045 | D0 | Bougouni | B | 1 | ||
BOO045 | D21 | Bougouni | A | |||
BOO057 | D0 | Bougouni | A | B | 1 | |
BOO057 | D28 | Bougouni | AB | A | ||
BOO072 | D0 | Bougouni | AB | A | B | 1 |
BOO072 | D28 | Bougouni | A | 9 | A | |
BOO073 | D0 | Bougouni | AD | 1 | ||
BOO073 | D21 | Bougouni | B | |||
BAD077 | D0 | Bandiagara | AB | A | 1 | |
BAD077 | D21 | Bandiagara | B | B | ||
BAD081 | D0 | Bandiagara | B | A | A | 1 |
BAD081 | D26 | Bandiagara | AB | 9 | B | |
BAD088 | D0 | Bandiagara | A | A | 1 | |
BAD088 | D28 | Bandiagara | AB | B | ||
BAD097 | D0 | Bandiagara | AB | 1 | ||
BAD097 | D21 | Bandiagara | C | |||
BAD101 | D0 | Bandiagara | A | 1 | ||
BAD101 | D21 | Bandiagara | CD | |||
BAD120 | D0 | Bandiagara | D | 1 | ||
BAD120 | D28 | Bandiagara | A |
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Parameters at Inclusion | Bougouni 2017 N = 126 | Bougouni 2018 N = 124 | Bandiagara 2017–2018 N = 125 |
---|---|---|---|
Age (Year) Average (range) | 10.6 (2–40) | 11.0 (2–60) | 11.5 (1–36) |
Age groups, n (%) | |||
≤5 years | 17 (15.6) | 23 (18.5) | 13 (10.4) |
6–12 years | 64 (58.7) | 69 (55.6) | 75 (60.0) |
≥13 years | 28 (25.7) | 32 (25.8) | 37 (29.6) |
Sex, n (%) | |||
Male | 39 (36.1) | 57 (46.0) | 35 (36.5) |
Female | 69 (63.9) | 67 (54.0) | 61 (63.5) |
Average weight (kg) (range) | 30.1 (6.0–96.3) | 29.5 (8.6–83.1) | 34.1 (10–90) |
Average temperature (°C) (range) | 37.6 (35.7–40) | 38.2 (35.8–41.3) | 38.2 (35.8–40.7) |
Fever (≥37.5 °C), n (%) | 89 (70.6) | 96 (77.4) | 99 (79.2) |
Vomiting, n (%) | 7 (5.6) | 21 (16.9) | 50 (40.0) |
Parasite density geometric mean (range) | 33.200 (1000–190.000) | 50.426 (1040–199.320) | 41.485 (1040–181.320) |
Gametocytemia, n (%) | 0 | 5 (4.0) | 7 (5.6) |
Average hemoglobin (g/dL), (range) | 12.2 (9.1–16) | 11.8 (8.1–17.7) | 12.2 (8.0–16) |
Anemia (Hb < 11 g/dL), n (%) | 31 (24.6) | 41 (33.1) | 22 (17.6) |
Artemether-lumefantrine | Bougouni 2017 | Bougouni 2018 | Bandiagara 2017–2018 | Total |
---|---|---|---|---|
Variable | N = 126 | N = 124 | N = 125 | N = 375 |
ACPR a (uncorrected) n | 103 | 87 | 119 | 309 |
ETF b n | 0 | 0 | 0 | 0 |
LCF c n | 0 | 0 | 0 | 0 |
LPF d n | 14 | 33 | 6 | 53 |
New infections (with PCR) n | 14 | 33 | 6 | 53 |
Recrudescences (with PCR) n | 0 | 0 | 0 | 0 |
No treatment outcome (loss to follow-up or withdrawn) n | 9 | 4 | 0 | 13 |
PP e day-28 efficacy (PCR-uncorrected) n/N (%, IC) | 103/117 (88.0, 82.1–93.9) | 87/120 (72.5, 64.5–80.5) | 119/125 (95.0, 91.2–98.8) | 309/362 (85.4, 81.8–98.4) |
PP day-28 efficacy (PCR-corrected) n/N (%) | 103/103 (100) | 87/87 (100) | 119/119 (100) | 309/309 (100) |
Artemether-Lumefantrine | Study Sites | Total N = 375 | ||
---|---|---|---|---|
Bougouni, 2017 N = 126 | Bougouni, 2018 N = 124 | Bandiagara, 2017–2018 N = 125 | ||
Vomiting post-dosing 1, 2 or 3 n (%) | 1 (0.8) | 4 (3.2) | 9 (7.2) | 14 (3.7) |
Diarrhea n (%) | 3 (2.4) | 1 (0.8) | 7 (5.6) | 11 (2.9) |
Abdominal pain n (%) | 3 (2.4) | 8 (6.5) | 10 (8.0) | 21 (5.6) |
Headaches n (%) | 0 (0) | 8 (6.5) | 4 (3.2) | 12 (3.2) |
Sites | Anemia | McNemar’s Test p Value | |
---|---|---|---|
Day 0 | Day 28 | ||
Bougouni, 2017 % (n/N) | 24.6 (31/126) | 16.0 (17/106) | <0.001 |
Bougouni, 2018 % (n/N) | 33.1 (41/124) | 28.8 (32/111) | <0.001 |
Bandiagara, 2017–2018 % (n/N) | 17.6 (22/125) | 9.7 (11/113) | <0.001 |
Total % (n/N) | 25.1 (94/375) | 18.2 (60/330) | <0.001 |
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Diarra, M.; Coulibaly, D.; Tapily, A.; Guindo, B.; Sanogo, K.; Koné, D.; Koné, Y.; Koné, K.; Bathily, A.; Yattara, O.; et al. Monitoring of the Sensitivity In Vivo of Plasmodium falciparum to Artemether-Lumefantrine in Mali. Trop. Med. Infect. Dis. 2021, 6, 13. https://doi.org/10.3390/tropicalmed6010013
Diarra M, Coulibaly D, Tapily A, Guindo B, Sanogo K, Koné D, Koné Y, Koné K, Bathily A, Yattara O, et al. Monitoring of the Sensitivity In Vivo of Plasmodium falciparum to Artemether-Lumefantrine in Mali. Tropical Medicine and Infectious Disease. 2021; 6(1):13. https://doi.org/10.3390/tropicalmed6010013
Chicago/Turabian StyleDiarra, Modibo, Drissa Coulibaly, Amadou Tapily, Boureima Guindo, Koualy Sanogo, Diakalia Koné, Youssouf Koné, Karim Koné, Aboudramane Bathily, Oumar Yattara, and et al. 2021. "Monitoring of the Sensitivity In Vivo of Plasmodium falciparum to Artemether-Lumefantrine in Mali" Tropical Medicine and Infectious Disease 6, no. 1: 13. https://doi.org/10.3390/tropicalmed6010013