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Efficacy and safety...
Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated malaria and prevalence of Pfk13 and Pfmdr1 polymorphisms after a decade of using artemisinin-based combination therapy in mainland Tanzania
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- Ishengoma, Deus S. (författare)
- Natl Inst Med Res, Tanga Res Ctr, Tanga, Tanzania
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- Mandara, Celine I. (författare)
- Natl Inst Med Res, Tanga Res Ctr, Tanga, Tanzania;Kilimanjaro Christian Med Univ Coll, Kilimanjaro Christian Med Ctr, Moshi, Tanzania
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- Francis, Filbert (författare)
- Karolinska Institutet
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- Talundzic, Eldin (författare)
- Ctr Dis Control & Prevent, Malaria Branch, Div Parasit Dis & Malaria, Atlanta, GA USA
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- Lucchi, Naomi W. (författare)
- Ctr Dis Control & Prevent, Malaria Branch, Div Parasit Dis & Malaria, Atlanta, GA USA
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- Ngasala, Billy (författare)
- Uppsala universitet,Internationell barnhälsa och nutrition,Muhimbili Univ Hlth & Allied Sci, Dept Parasitol, Sch Publ Hlth, Dar Es Salaam, Tanzania
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- Kabanywanyi, Abdunoor M. (författare)
- Ifakara Hlth Inst, Dar Es Salaam, Tanzania
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- Mahende, Muhidin K. (författare)
- Ifakara Hlth Inst, Dar Es Salaam, Tanzania
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- Kamugisha, Erasmus (författare)
- Catholic Univ Hlth & Allied Sci, Bugando Med Ctr, Mwanza, Tanzania
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- Kavishe, Reginald A. (författare)
- Kilimanjaro Christian Med Univ Coll, Kilimanjaro Christian Med Ctr, Moshi, Tanzania
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- Muro, Florida (författare)
- Kilimanjaro Christian Med Univ Coll, Kilimanjaro Christian Med Ctr, Moshi, Tanzania
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- Mohamed, Ally (författare)
- Natl Malaria Control Programme, Ocean Rd Luthuli Ave NIMR Complex, Dar Es Salaam, Tanzania
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- Mandike, Renata (författare)
- Natl Malaria Control Programme, Ocean Rd Luthuli Ave NIMR Complex, Dar Es Salaam, Tanzania
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- Mkude, Sigsbert (författare)
- Natl Malaria Control Programme, Ocean Rd Luthuli Ave NIMR Complex, Dar Es Salaam, Tanzania
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- Chacky, Frank (författare)
- Natl Malaria Control Programme, Ocean Rd Luthuli Ave NIMR Complex, Dar Es Salaam, Tanzania
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- Paxton, Lynn (författare)
- Ctr Dis Control & Prevent, Malaria Branch, Div Parasit Dis & Malaria, Atlanta, GA USA
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- Greer, George (författare)
- US Embassy, US Presidents Malaria Initiat, US Agcy Int Dev, Dar Es Salaam, Tanzania
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- Kitojo, Chonge A. (författare)
- US Embassy, US Presidents Malaria Initiat, US Agcy Int Dev, Dar Es Salaam, Tanzania
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- Njau, Ritha (författare)
- WHO, Country Off, Dar Es Salaam, Tanzania
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- Martin, Troy (författare)
- Fred Hutchinson Canc Res Ctr, HIV Vaccine Trials Network, 1124 Columbia St, Seattle, WA 98104 USA
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- Venkatesan, Meera (författare)
- US Agcy Int Dev, US Presidents Malaria Initiat, Washington, DC 20523 USA
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- Warsame, Marian (författare)
- WHO, Global Malaria Programme, 20 Ave Appia, CH-1211 Geneva 27, Switzerland;Gothenburg Univ, Gothenburg, Sweden
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- Halsey, Eric S. (författare)
- Ctr Dis Control & Prevent, Malaria Branch, Div Parasit Dis & Malaria, Atlanta, GA USA;Ctr Dis Control & Prevent, US Presidents Malaria Initiat, Atlanta, GA USA
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- Udhayakumar, Venkatachalam (författare)
- Ctr Dis Control & Prevent, Malaria Branch, Div Parasit Dis & Malaria, Atlanta, GA USA
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(creator_code:org_t)
- 2019-03-21
- 2019
- Engelska.
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Ingår i: Malaria Journal. - : BMC. - 1475-2875. ; 18
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://malariajourn...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- Background: The World Health Organization recommends regular therapeutic efficacy studies (TES) to monitor the performance of first and second-line anti-malarials. In 2016, efficacy and safety of artemether-lumefantrine (AL) for the treatment of uncomplicated falciparum malaria were assessed through a TES conducted between April and October 2016 at four sentinel sites of Kibaha, Mkuzi, Mlimba, and Ujiji in Tanzania. The study also assessed molecular markers of artemisinin and lumefantrine (partner drug) resistance.Methods: Eligible patients were enrolled at the four sites, treated with standard doses of AL, and monitored for 28 days with clinical and laboratory assessments. The main outcomes were PCR corrected cure rates, day 3 positivity rates, safety of AL, and prevalence of single nucleotide polymorphisms in Plasmodium falciparum kelch 13 (Pfk13) (codon positions: 440-600) and P. falciparum multi-drug resistance 1 (Pfmdr1) genes (codons: N86Y, Y184F and D1246Y), markers of artemisinin and lumefantrine resistance, respectively.Results: Of 344 patients enrolled, three withdrew, six were lost to follow-up; and results were analysed for 335 (97.4%) patients. Two patients had treatment failure (one early treatment failure and one recrudescent infection) after PCR correction, yielding an adequate clinical and parasitological response of > 98%. Day 3 positivity rates ranged from 0 to 5.7%. Common adverse events included cough, abdominal pain, vomiting, and diarrhoea. Two patients had serious adverse events; one died after the first dose of AL and another required hospitalization after the second dose of AL (on day 0) but recovered completely. Of 344 samples collected at enrolment (day 0), 92.7% and 100% were successfully sequenced for Pfk13 and Pfmdr1 genes, respectively. Six (1.9%) had non-synonymous mutations in Pfk13, none of which had been previously associated with artemisinin resistance. For Pfmdr1, the NFD haplotype (codons N86, 184F and D1246) was detected in 134 (39.0%) samples; ranging from 33.0% in Mlimba to 45.5% at Mkuzi. The difference among the four sites was not significant (p = 0.578). All samples had a single copy of the Pfmdr1 gene.Conclusion: The study indicated high efficacy of AL and the safety profile was consistent with previous reports. There were no known artemisinin-resistance Pfk13 mutations, but there was a high prevalence of a Pfmdr1 haplotype associated with reduced sensitivity to lumefantrine (but no reduced efficacy was observed in the subjects). Continued TES and monitoring of markers of resistance to artemisinin and partner drugs is critical for early detection of resistant parasites and to inform evidence-based malaria treatment policies.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinsk bioteknologi -- Medicinsk bioteknologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Medical Biotechnology -- Medical Biotechnology (hsv//eng)
Nyckelord
- Efficacy
- Safety
- Artemether-lumefantrine
- Falciparum malaria
- Tanzania
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Ishengoma, Deus ...
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Mandara, Celine ...
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Francis, Filbert
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Talundzic, Eldin
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Lucchi, Naomi W.
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Ngasala, Billy
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visa fler...
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Kabanywanyi, Abd ...
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Mahende, Muhidin ...
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Kamugisha, Erasm ...
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Kavishe, Reginal ...
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Muro, Florida
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Mohamed, Ally
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Mandike, Renata
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Mkude, Sigsbert
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Chacky, Frank
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Paxton, Lynn
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Greer, George
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Kitojo, Chonge A ...
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Njau, Ritha
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Martin, Troy
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Venkatesan, Meer ...
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Warsame, Marian
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Halsey, Eric S.
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Udhayakumar, Ven ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Infektionsmedici ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Medicinsk biotek ...
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- Artiklar i publikationen
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Malaria Journal
- Av lärosätet
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Uppsala universitet
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Karolinska Institutet