Similar efficacy and tolerability of double-dose chloroquine and artemether-lumefantrine for treatment of Plasmodium falciparum infection in Guinea-Bissau: a randomized trial.
BACKGROUND: In 2008, Guinea-Bissau introduced artemether-lumefantrine for treatment of uncomplicated malaria. Previously, 3 times the standard dose of chloroquine, that was probably efficacious against Plasmodium falciparum with the resistance-associated chloroquine-resistance transporter (pfcrt) 7...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Journal article |
| Language: | English |
| Published: |
2011
|
| _version_ | 1797077538033369088 |
|---|---|
| author | Ursing, J Kofoed, P Rodrigues, A Blessborn, D Thoft-Nielsen, R Björkman, A Rombo, L |
| author_facet | Ursing, J Kofoed, P Rodrigues, A Blessborn, D Thoft-Nielsen, R Björkman, A Rombo, L |
| author_sort | Ursing, J |
| collection | OXFORD |
| description | BACKGROUND: In 2008, Guinea-Bissau introduced artemether-lumefantrine for treatment of uncomplicated malaria. Previously, 3 times the standard dose of chloroquine, that was probably efficacious against Plasmodium falciparum with the resistance-associated chloroquine-resistance transporter (pfcrt) 76T allele, was routinely used. The present study compared the efficacy and tolerability of a double standard dose of chloroquine with the efficacy and tolerability of artemether-lumefantrine. METHODS: In a randomized open-label clinical trial, artemether-lumefantrine or chloroquine (50 mg/kg) were given as 6 divided doses over 3 days to children aged 6 months--15 years who had uncomplicated P. falciparum monoinfection. Drug concentrations were measured on day 7. P. falciparum multidrug resistance gene N86Y and pfcrt K76T alleles were identified. RESULTS: The polymerase chain reaction-adjusted day 28 and 42 treatment efficacies were 162 (97%) of 168 and 155 (97%) of 161, respectively, for artemether-lumefantrine and 150 (95%) of 158 and 138 (94%) of 148, respectively, for chloroquine. When parasites with resistance-associated pfcrt 76T were treated, the day 28 efficacy of chloroquine was 87%. No severe drug-related adverse events were detected. Symptom resolution was similar with both treatments. CONCLUSIONS: Both treatments achieved the World Health Organization-recommended efficacy for antimalarials that will be adopted as policy. High-dose chloroquine treatment regimes should be further evaluated with the aim of assessing chloroquine as a potential partner drug to artemisinin derivatives. Clinical trials registration. NCT00426439. |
| first_indexed | 2024-03-07T00:19:31Z |
| format | Journal article |
| id | oxford-uuid:7c09f4c8-ccce-4efe-b48b-5e5423c099bd |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T00:19:31Z |
| publishDate | 2011 |
| record_format | dspace |
| spelling | oxford-uuid:7c09f4c8-ccce-4efe-b48b-5e5423c099bd2022-03-26T20:54:29ZSimilar efficacy and tolerability of double-dose chloroquine and artemether-lumefantrine for treatment of Plasmodium falciparum infection in Guinea-Bissau: a randomized trial.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:7c09f4c8-ccce-4efe-b48b-5e5423c099bdEnglishSymplectic Elements at Oxford2011Ursing, JKofoed, PRodrigues, ABlessborn, DThoft-Nielsen, RBjörkman, ARombo, L BACKGROUND: In 2008, Guinea-Bissau introduced artemether-lumefantrine for treatment of uncomplicated malaria. Previously, 3 times the standard dose of chloroquine, that was probably efficacious against Plasmodium falciparum with the resistance-associated chloroquine-resistance transporter (pfcrt) 76T allele, was routinely used. The present study compared the efficacy and tolerability of a double standard dose of chloroquine with the efficacy and tolerability of artemether-lumefantrine. METHODS: In a randomized open-label clinical trial, artemether-lumefantrine or chloroquine (50 mg/kg) were given as 6 divided doses over 3 days to children aged 6 months--15 years who had uncomplicated P. falciparum monoinfection. Drug concentrations were measured on day 7. P. falciparum multidrug resistance gene N86Y and pfcrt K76T alleles were identified. RESULTS: The polymerase chain reaction-adjusted day 28 and 42 treatment efficacies were 162 (97%) of 168 and 155 (97%) of 161, respectively, for artemether-lumefantrine and 150 (95%) of 158 and 138 (94%) of 148, respectively, for chloroquine. When parasites with resistance-associated pfcrt 76T were treated, the day 28 efficacy of chloroquine was 87%. No severe drug-related adverse events were detected. Symptom resolution was similar with both treatments. CONCLUSIONS: Both treatments achieved the World Health Organization-recommended efficacy for antimalarials that will be adopted as policy. High-dose chloroquine treatment regimes should be further evaluated with the aim of assessing chloroquine as a potential partner drug to artemisinin derivatives. Clinical trials registration. NCT00426439. |
| spellingShingle | Ursing, J Kofoed, P Rodrigues, A Blessborn, D Thoft-Nielsen, R Björkman, A Rombo, L Similar efficacy and tolerability of double-dose chloroquine and artemether-lumefantrine for treatment of Plasmodium falciparum infection in Guinea-Bissau: a randomized trial. |
| title | Similar efficacy and tolerability of double-dose chloroquine and artemether-lumefantrine for treatment of Plasmodium falciparum infection in Guinea-Bissau: a randomized trial. |
| title_full | Similar efficacy and tolerability of double-dose chloroquine and artemether-lumefantrine for treatment of Plasmodium falciparum infection in Guinea-Bissau: a randomized trial. |
| title_fullStr | Similar efficacy and tolerability of double-dose chloroquine and artemether-lumefantrine for treatment of Plasmodium falciparum infection in Guinea-Bissau: a randomized trial. |
| title_full_unstemmed | Similar efficacy and tolerability of double-dose chloroquine and artemether-lumefantrine for treatment of Plasmodium falciparum infection in Guinea-Bissau: a randomized trial. |
| title_short | Similar efficacy and tolerability of double-dose chloroquine and artemether-lumefantrine for treatment of Plasmodium falciparum infection in Guinea-Bissau: a randomized trial. |
| title_sort | similar efficacy and tolerability of double dose chloroquine and artemether lumefantrine for treatment of plasmodium falciparum infection in guinea bissau a randomized trial |
| work_keys_str_mv | AT ursingj similarefficacyandtolerabilityofdoubledosechloroquineandartemetherlumefantrinefortreatmentofplasmodiumfalciparuminfectioninguineabissauarandomizedtrial AT kofoedp similarefficacyandtolerabilityofdoubledosechloroquineandartemetherlumefantrinefortreatmentofplasmodiumfalciparuminfectioninguineabissauarandomizedtrial AT rodriguesa similarefficacyandtolerabilityofdoubledosechloroquineandartemetherlumefantrinefortreatmentofplasmodiumfalciparuminfectioninguineabissauarandomizedtrial AT blessbornd similarefficacyandtolerabilityofdoubledosechloroquineandartemetherlumefantrinefortreatmentofplasmodiumfalciparuminfectioninguineabissauarandomizedtrial AT thoftnielsenr similarefficacyandtolerabilityofdoubledosechloroquineandartemetherlumefantrinefortreatmentofplasmodiumfalciparuminfectioninguineabissauarandomizedtrial AT bjorkmana similarefficacyandtolerabilityofdoubledosechloroquineandartemetherlumefantrinefortreatmentofplasmodiumfalciparuminfectioninguineabissauarandomizedtrial AT rombol similarefficacyandtolerabilityofdoubledosechloroquineandartemetherlumefantrinefortreatmentofplasmodiumfalciparuminfectioninguineabissauarandomizedtrial |