Efficacy, safety, and tolerability of albendazole and ivermectin based regimens for the treatment of microfilaraemic loiasis in adult patients in Gabon: A randomized controlled assessor blinded clinical trial
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Efficacy, safety, and tolerability of albendazole and ivermectin based regimens for the treatment of microfilaraemic loiasis in adult patients in Gabon: A randomized controlled assessor blinded clinical trial. / Zoleko-Manego, Rella; Kreuzmair, Ruth; Veletzky, Luzia; Ndzebe-Ndoumba, Wilfrid; Ekoka Mbassi, Dorothea; Okwu, Dearie G; Dimessa-Mbadinga-Weyat, Lia B; Houtsa-Temgoua, Roselyne D; Mischlinger, Johannes; McCall, Matthew B B; Kresmner, Peter G; Agnandji, Selidji T; Lell, Betrand; Adegnika, Ayôla A; Mombo-Ngoma, Ghyslain; Ramharter, Michael.
in: PLOS NEGLECT TROP D, Jahrgang 17, Nr. 8, 08.2023, S. e0011584.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Efficacy, safety, and tolerability of albendazole and ivermectin based regimens for the treatment of microfilaraemic loiasis in adult patients in Gabon: A randomized controlled assessor blinded clinical trial
AU - Zoleko-Manego, Rella
AU - Kreuzmair, Ruth
AU - Veletzky, Luzia
AU - Ndzebe-Ndoumba, Wilfrid
AU - Ekoka Mbassi, Dorothea
AU - Okwu, Dearie G
AU - Dimessa-Mbadinga-Weyat, Lia B
AU - Houtsa-Temgoua, Roselyne D
AU - Mischlinger, Johannes
AU - McCall, Matthew B B
AU - Kresmner, Peter G
AU - Agnandji, Selidji T
AU - Lell, Betrand
AU - Adegnika, Ayôla A
AU - Mombo-Ngoma, Ghyslain
AU - Ramharter, Michael
N1 - Copyright: © 2023 Zoleko-Manego et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2023/8
Y1 - 2023/8
N2 - BACKGROUND: There is a lack of systematic evidence for strategies to control loiasis transmission in highly endemic regions. Here we assessed albendazole and ivermectin based treatment regimens to reduce Loa loa microfilaraemia in Gabon.METHODS: Eligible adult patients with L. loa microfilaraemia between 5,000 and 50,000 microfilariae/ml were randomized to either a control or one of three intervention groups (1:2:2:2 allocation ratio) consisting of three-week twice daily 400mg oral albendazole followed by 1) no treatment, 2) two further weeks of twice daily 400mg albendazole, or 3) a single dose of ivermectin in this open label randomized assessor blinded controlled clinical trial. The primary outcome was the proportion of participants with L. loa microfilaraemia ≤ 100 mf/ml at Day 168.RESULTS: In the efficacy-population of 42 patients 0 (0%; control group), 1 (9%; 3-week albendazole), 5 (39%; 5-weeks albendazole) and 2 (22%; 3-week albendazole plus single dose ivermectin) participants met the primary outcome of microfilaraemia below 100/ml at day 168. A 80-90% reduction of microfilaraemia was observed in the active treatment groups.CONCLUSION: The 5-week regimen of albendazole or a 3-week regimen of albendazole followed by ivermectin were most efficacious to reduce microfilaraemia. All therapeutic regimens were well tolerated and safe.TRIAL REGISTRATION: Trial registered at the Pan-African Clinical Trials Registry: PACTR201807197019027.
AB - BACKGROUND: There is a lack of systematic evidence for strategies to control loiasis transmission in highly endemic regions. Here we assessed albendazole and ivermectin based treatment regimens to reduce Loa loa microfilaraemia in Gabon.METHODS: Eligible adult patients with L. loa microfilaraemia between 5,000 and 50,000 microfilariae/ml were randomized to either a control or one of three intervention groups (1:2:2:2 allocation ratio) consisting of three-week twice daily 400mg oral albendazole followed by 1) no treatment, 2) two further weeks of twice daily 400mg albendazole, or 3) a single dose of ivermectin in this open label randomized assessor blinded controlled clinical trial. The primary outcome was the proportion of participants with L. loa microfilaraemia ≤ 100 mf/ml at Day 168.RESULTS: In the efficacy-population of 42 patients 0 (0%; control group), 1 (9%; 3-week albendazole), 5 (39%; 5-weeks albendazole) and 2 (22%; 3-week albendazole plus single dose ivermectin) participants met the primary outcome of microfilaraemia below 100/ml at day 168. A 80-90% reduction of microfilaraemia was observed in the active treatment groups.CONCLUSION: The 5-week regimen of albendazole or a 3-week regimen of albendazole followed by ivermectin were most efficacious to reduce microfilaraemia. All therapeutic regimens were well tolerated and safe.TRIAL REGISTRATION: Trial registered at the Pan-African Clinical Trials Registry: PACTR201807197019027.
KW - Humans
KW - Adult
KW - Animals
KW - Albendazole/adverse effects
KW - Ivermectin/adverse effects
KW - Gabon
KW - Loiasis/drug therapy
KW - Clinical Protocols
KW - Fishes
U2 - 10.1371/journal.pntd.0011584
DO - 10.1371/journal.pntd.0011584
M3 - SCORING: Journal article
C2 - 37639396
VL - 17
SP - e0011584
JO - PLOS NEGLECT TROP D
JF - PLOS NEGLECT TROP D
SN - 1935-2735
IS - 8
ER -