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Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria in Uganda  [PDF]
Hasifa Bukirwa, Adoke Yeka, Moses R Kamya, Ambrose Talisuna, Kristin Banek, Nathan Bakyaita, John Bosco Rwakimari, Philip J Rosenthal, Fred Wabwire-Mangen, Grant Dorsey, Sarah G Staedke
PLOS ONE , 2006, DOI: 10.1371/journal.pctr.0010007
Abstract: Objectives To compare the efficacy and safety of artemisinin combination therapies for the treatment of uncomplicated falciparum malaria in Uganda. Design Randomized single-blind controlled trial. Setting Tororo, Uganda, an area of high-level malaria transmission. Participants Children aged one to ten years with confirmed uncomplicated P. falciparum malaria. Interventions Amodiaquine + artesunate or artemether–lumefantrine. Outcome Measures Risks of recurrent symptomatic malaria and recurrent parasitemia at 28 days, unadjusted and adjusted by genotyping to distinguish recrudescences and new infections. Results Of 408 participants enrolled, 403 with unadjusted efficacy outcomes were included in the per-protocol analysis. Both treatment regimens were highly efficacious; no recrudescences occurred in patients treated with amodiaquine + artesunate, and only two occurred in those treated with artemether–lumefantrine. However, recurrent malaria due to new infections was common. The unadjusted risk of recurrent symptomatic malaria was significantly lower for participants treated with artemether–lumefantrine than for those treated with amodiaquine + artesunate (27% versus 42%, risk difference 15%, 95% CI 5.9%–24.2%). Similar results were seen for the risk of recurrent parasitemia (51% artemether–lumefantrine versus 66% amodiaquine + artesunate, risk difference 16%, 95% CI 6.2%–25.2%). Amodiaquine + artesunate and artemether–lumefantrine were both well-tolerated. Serious adverse events were uncommon with both regimens. Conclusions Amodiaquine + artesunate and artemether–lumefantrine were both highly efficacious for treatment of uncomplicated malaria. However, in this holoendemic area, despite the excellent performance of both regimens in terms of efficacy, many patients experienced recurrent parasitemia due to new infections. Artemether–lumefantrine was superior to amodiaquine + artesunate for prevention of new infections. To maximize the benefit of artemisinin combination therapy in Africa, treatment should be integrated with strategies to prevent malaria transmission. The impact of frequent repeated therapy on the efficacy, safety, and cost-effectiveness of new artemisinin regimens should be further investigated. Trial Registration Controlled-Trials.com ISRCTN44534980
Parents’ perceptions, attitudes and acceptability of Treatment of childhood malaria with artemisinin combination therapies in Ghana
G.O Adjei, A.K Darkwah, B.Q Goka, C Bart-plang
Ghana Medical Journal , 2009,
Abstract: Background: There is little information on sociocultural and contextual factors that may influence attitudes of patients to new treatments, such as artemisinin combination therapies (ACT). Methods: Semi-structured questionnaires and focus group discussions were used to assess views of parents of children with uncomplicated malaria treated with ACT in a low socio-economic area in Accra, Ghana. Results: The majority of parents reported a favourable experience, in terms of perceived i) rapidity of symptom resolution, compared to their previous experience of other therapies for childhood malaria, or ii) when their experience was compared that of parents of children treated with monotherapy. The parents of children treated with ACT were more willing to pay for the treatment, or adhere to the full treatment course. The explanations given for adherence were consistent with conventional biomedical explanations. Although careseeking practices for childhood malaria were considered appropriate, perceived or real barriers to accessible health care were also important factors in the decision to seek treatment. Household dynamics and perceived inequities at the care-provider-patient interface were identified as having potential negative impact on care-seeking practices and adherence. Conclusions: Health education messages aimed at improving the response to childhood febrile illness should include other strategic stakeholders, such as decisionmakers at the household level. The effectiveness and implementation success of the ACT policy could be enhanced by highlighting and reinforcing messages intrinsic to these regimens. Integrating the views of caretakers during the clinical encounter was validated as an empowerment tool that could aid in the appropriate responses to childhood illness.
Effectiveness of combined intermittent preventive treatment for children and timely home treatment for malaria control
Collins K Ahorlu, Kwadwo A Koram, Atsu K Seakey, Mitchell G Weiss
Malaria Journal , 2009, DOI: 10.1186/1475-2875-8-292
Abstract: The study combined home-based delivery of IPTC among six to 60 months old and home treatment of suspected febrile malaria illness within 24 hours. All children between six and 60 months of age received intermittent preventive treatment using amodiaquine and artesunate, delivered by community assistants every four months (three times in 12 months). Malaria parasite prevalence surveys were conducted before the first and after the third dose of IPTC.Parasite prevalence was reduced from 25% to 3% (p < 0.00, Mann-Whitney) one year after the inception of the two interventions. At baseline, 13.8% of the children were febrile (axillary temperature greater than or equal to 37.5 degree Celsius) compared to 2.2% at evaluation (post IPTC3 combined with timely home management of fever) (p < 0.00, Mann-Whitney).The evaluation result indicates that IPTC given three times in a year combined with timely treatment of febrile malaria illness, impacts significantly on the parasite prevalence. The marked reduction in the parasite prevalence with this strategy points to the potential for reducing malaria-related childhood morbidity and mortality, and this should be explored by control programme managers.Malaria is estimated to cause between 300 and 500 million clinical cases with about 700,000 to 1.6 million deaths every year. About 94% of these deaths are believed to occur in sub-Saharan Africa, which is also the most resource-limited continent on the globe [1,2]. Malaria remains a major cause of morbidity and mortality in Ghana, accounting for over 40% of outpatient clinic visits and about 20% of deaths in children under five years of age [3]. The use of artemisinin-based combination therapy (ACT) for the treatment of uncomplicated falciparum malaria has been shown to provide effective treatment against falciparum malaria and slow down the spread of drug resistance [1]. In line with this recommendation and the increasing treatment failure rate of chloroquine [4], the Ghana National Mal
Relationship between treatment-seeking behaviour and artemisinin drug quality in Ghana
Eili Y Klein, Ian A Lewis, Christina Jung, Manuel Llinás, Simon A Levin
Malaria Journal , 2012, DOI: 10.1186/1475-2875-11-110
Abstract: Caregivers of children less than 5 years of age were interviewed on their knowledge of malaria and their choices for treatment. Artemisinin drugs were then purchased from sellers that caregivers preferred or had previously patronized. The active ingredients were quantified by nuclear magnetic resonance spectroscopy.A negative relationship was anticipated between the education level of caregivers and the quality of anti-malarial drugs purchased. However, of the 33 drugs collected from 16 different shops, only one contained less than 80% of its purported active ingredient, and most drugs were within 90% of their listed amounts. No link was found between drug quality and price. Nonetheless, while ACT is the recommended first-line treatment in Ghana, 21% of the drugs collected were artemisinin monotherapy, and 27% of the ACT was not co-formulated. Among caregivers, higher education was found to be associated with both an increased likelihood of seeking treatment in a clinic first, as opposed to visiting drug shops or using herbal remedies, and with purchasing drugs from licensed sellers.Surprisingly, drug quality was found to be uniformly high and thus no significant relationship between price, treatment-seeking behaviour and the content of the active ingredients was observed. However, artemisinin monotherapy, which the WHO considers inappropriate therapy, was still widely available in Ghana in 2010. Monotherapy was more likely to be available in unlicensed vendors where less-educated caregivers generally shopped. This linkage between education, treatment-seeking behaviour and drug availability suggests that the global subsidy to reduce the cost of co-formulated ACT can play a significant role in increasing its availability.It is estimated that 350 to 500 million Africans fall sick with malaria each year [1]; many of them have poor access to public health facilities and rely primarily on self-medication through the unregulated private and informal drug sector [2]. A lar
Reversible Audiometric Threshold Changes in Children with Uncomplicated Malaria  [PDF]
George O. Adjei,Bamenla Q. Goka,Emmanuel Kitcher,Onike P. Rodrigues,Ebenezer Badoe,Jorgen A. L. Kurtzhals
Journal of Tropical Medicine , 2013, DOI: 10.1155/2013/360540
Abstract: Background. Plasmodium falciparum malaria, as well as certain antimalarial drugs, is associated with hearing impairment in adults. There is little information, however, on the extent, if any, of this effect in children, and the evidence linking artemisinin combination therapies (ACTs) with hearing is inconclusive. Methods. Audiometry was conducted in children with uncomplicated malaria treated with artesunate-amodiaquine ( ), artemether-lumefantrine ( ), or amodiaquine ( ) in Accra, Ghana. Audiometry was repeated 3, 7, and 28 days later and after 9 months. Audiometric thresholds were compared with those of a control group of children ( ) from the same area. Findings. During the acute stage, hearing threshold levels of treated children were significantly elevated compared with controls ( ). The threshold elevations persisted up to 28 days, but no differences in hearing thresholds were evident between treated children and controls after 9 months. The hearing thresholds of children treated with the two ACT regimens were comparable but lower than those of amodiaquine-treated children during acute illness. Interpretation. Malaria is the likely cause of the elevated hearing threshold levels during the acute illness, a finding that has implications for learning and development in areas of intense transmission, as well as for evaluating potential ototoxicity of new antimalarial drugs. 1. Background Acute Plasmodium falciparum malaria is associated with varying degrees of neurological involvement, depending on the severity. Few studies have, however, investigated the effect of the disease on hearing specifically in those with uncomplicated malaria. Furthermore, several antimalarial drugs, including quinine [1, 2], chloroquine [3], and mefloquine [4], have been associated with ototoxicity, and certain artemisinin derivatives have also been associated with neuro- or ototoxicity in various animal species [5–9]. Although human studies that have evaluated possible artemisinin-related effects on hearing have, with the exception of one study [10], concluded lack of any clinically relevant ototoxicity or neurotoxicity [11–15], the majority of these studies have been done in adults, in spite of the fact that children are the subgroup of patients who, because of their still developing nervous systems, are more susceptible to such potential treatment-related effects. The lack of studies evaluating the potential effects of newly introduced antimalarial drugs on hearing in children is due to the difficulties in conducting serial audiometric measurements in childhood
Possible treatment failure of artemether-lumefantrine in an Italian traveler with uncomplicated falciparum malaria.  [cached]
Ernestina Carla Repetto,Claudio Giacomazzi,Antonio Traverso
Mediterranean Journal of Hematology and Infectious Diseases , 2011, DOI: 10.4084/mjhid.2011.
Abstract: Artemisinin-combination therapies (ACTs) are recommended for the treatment of uncomplicated malaria in endemic areas with multidrug resistant Plasmodium falciparum. We report a case of possible artemether-lumefantrine failure in an Italian traveler with uncomplicated P. falciparum malaria imported from Democratic Republic of Congo.
Efficacy of artemether-lumefantrine, the nationally-recommended artemisinin combination for the treatment of uncomplicated falciparum malaria, in southern Laos
Mayfong Mayxay, Maniphone Khanthavong, Odai Chanthongthip, Mallika Imwong, Tiengkham Pongvongsa, Bouasy Hongvanthong, Samlane Phompida, Viengxay Vanisaveth, Nicholas J White, Paul N Newton
Malaria Journal , 2012, DOI: 10.1186/1475-2875-11-184
Abstract: The efficacy of a three-day, twice daily oral artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Xepon District, Savannakhet Province, southern Laos was studied over 42?days follow-up. This was part of a trial of thiamin supplementation in falciparum malaria.Of 630 patients with P. falciparum enrolled in the trial of thiamin treatment, 549 (87%, 357 children ≤15?years and 192 adults) were included in this study. The per protocol 42-day cure rates were 97% (524/541) [96% (337/352) for children and 99% (187/189) for adults, p?=?0.042]. By conventional intention-to-treat analysis, the 42-day cure rates adjusted for re-infection, were 97% (532/549) [96% (342/357) in children and 99% (190/192) in adults, p?=?0.042]. The proportion of patients who remained parasitaemic at day 1 after treatment was significantly higher in children [33% (116/356)] compared to adults [15% (28/192)] (p?<?0.001) and only one adult patient had detectable parasitaemia on day 2. There were no serious adverse events. Potential side effects after treatment were reported more commonly in adults (32%) compared to children (15%) (p?<?0.001). Patients with recrudescent infections were significantly younger, had longer mean time to fever clearance, and had longer median time to parasite clearance compared to those who were cured.The current nationally-recommended anti-malarial treatment (artemether-lumefantrine) remains highly efficacious for the treatment of uncomplicated falciparum malaria five years after introduction in Laos. Regular monitoring is required in case artemisinin-resistant P. falciparum parasites should appear.ISRCTN85411059.
Efficacy and safety of artemisinin-based antimalarial in the treatment of uncomplicated malaria in children in southern Tanzania
Abdunoor M Kabanywanyi, Alex Mwita, Deborah Sumari, Renata Mandike, Kefas Mugittu, Salim Abdulla
Malaria Journal , 2007, DOI: 10.1186/1475-2875-6-146
Abstract: An in vivo efficacy study was conducted at Ipinda and Mlimba health facilities between May and November 2004. The study recruited children aged 6–59 months presenting with symptoms of uncomplicated malaria, history of fever or an axillary temperature ≥37.5°C; mono infection with Pasmodium falciparum (2,000–200,000 parasites/μl). Patients were randomized to received either SP or amodiaquine monotherapy or treated with standard doses of AS+AQ in Mlimba and Coartem in Kyela and followed-up for 28 days to assess treatment responses. This study reports results of the combination therapies.A total of 157 children (76 in Mlimba and 99 in Kyela) who were enrolled in to the study and treated with either AL or AS+AQ were successfully followed-up. Both combinations were tolerated and effected rapid fever and parasite clearance. The crude ACPRs were 80 (87%) and 41 (63%) for AL and AS+AQ respectively. However, after PCR adjustments the corresponding figures raised to 100% (n = 86) and 93.8% (n = 45) in AL and AS+AQ groups, respectively. The mean haemoglobin improved moderately from day 0 to day 28 by 1 g/dl in AL and 0.4 g/dl in AS+AQ treatment group and was statistically significant (p < 0.001 both).These findings provide substantial evidence that AL is highly efficacious in areas of high resistance of SP and supported the country's decision to switch from SP monotherapy to AL.The emergence and spread of Plasmodium falciparum resistance to commonly used antimalarials such as chloroquine (CQ) and sulphadoxine/pyrimethamine (SP) has posed major challenges to malaria control in sub-Saharan Africa. In the face of escalated resistance to these widely used and long utilized antimalarial the World Health Organization (WHO) currently recommends the use of artemisinin combination therapies (ACTs) as the first line treatment of malaria in sub-Saharan Africa [1-3]. Several countries in the region have started implementing the use of ACTs as the first line drug. Despite these recommendati
The efficacy and tolerability of artemisinin-piperaquine (Artequick?) versus artesunate-amodiaquine (Coarsucam?) for the treatment of uncomplicated Plasmodium falciparum malaria in south-central Vietnam
Nguyen Xuan Thanh, Trieu Nguyen Trung, Nguyen Chinh Phong, Huynh Hong Quang, Bui Dai, G Dennis Shanks, Marina Chavchich, Michael D Edstein
Malaria Journal , 2012, DOI: 10.1186/1475-2875-11-217
Abstract: A randomized, open-label trial was conducted comparing the efficacy of a two-day regimen of ARPQ (~2.8?mg/kg artemisinin plus ~17.1?mg/kg of piperaquine per day) and a three-day regimen of ASAQ (~4.7?mg/kg of artesunate plus ~12.6?mg/kg of amodiaquine per day) for the treatment of children and adults with uncomplicated falciparum malaria. Primary efficacy endpoint was day 42, PCR-corrected, parasitological cure rate. Secondary endpoints were parasite and fever clearance times and tolerability.Of 128 patients enrolled, 63 were administered ARPQ and 65 ASAQ. Of the patients who completed the 42?days follow-up period or had a recurrence of malaria, 55 were on ARPQ (30 children, 25 adults) and 59 were on ASAQ (31 children, 28 adults). Recrudescent parasitaemia was PCR-confirmed for one patient in each treatment group, with cure rates at day 42 of 98% (95% CI: 88–100) for both forms of ACT. The median parasite clearance time was significantly slower in the ARPQ group compared with the ASAQ group (48?h vs. 36?h, P<0.001) and fever clearance times were shorter in the ASAQ group (12?h vs. 24?h, P?=?0.07). The two forms of ACT were well tolerated with no serious adverse events.Both forms of ACT were highly efficacious in the treatment of uncomplicated P. falciparum malaria. Although the two-day course of ARPQ was equally as effective as the three-day course of ASAQ, parasite and fever clearance times were shorter with ASAQ. Further studies are warranted in different regions of Vietnam to determine the nationwide efficacy of ASAQ.Australian New Zealand Clinical Trials Registry Number, ACTRN12609000816257
Efficacy and safety of artesunate plus amodiaquine in routine use for the treatment of uncomplicated malaria in Casamance, southern Sénégal
Philippe Brasseur, Patrice Agnamey, Oumar Gaye, Michel Vaillant, Walter RJ Taylor, Piero L Olliaro
Malaria Journal , 2007, DOI: 10.1186/1475-2875-6-150
Abstract: Artesunate plus amodiaquine (AS+AQ) was used to treat slide-proven Plasmodium falciparum-infected patients of all ages in the Oussouye district, Casamance, Senegal, over a period of six years (2000 to 2005). Efficacy, by Kaplan Meier survival analysis (n = 966), and safety (adverse event rates, n = 752) were determined over 28 days. A weight-based dosing regimen was used for the loose tablets during 2000–2003 (n = 731) and a commercially available co-blister was used during 2004–2005 (n = 235).Annual crude (non PCR corrected) rates remained stable over the study period [range 88.5–96.7%; overall 94.6 (95% CI 92.9–95.9)]. Nine co-blister treated patients (0.9%) withdrew because of drug-related adverse events; seven had gastrointestinal complaints of whom two were hospitalized for vomiting. By Day 28, the mean total bilirubin (n = 72), AST (n = 94) and ALT (n = 95) values decreased. Three patients had Day 28 AST/ALT values > 40 < 200 IU/L. Changes in white cell counts were unremarkable (n = 87).AS+AQ in combination was highly efficacious and well-tolerated in this area and justifies the decision to use it as first line treatment. Long-term monitoring of safety and efficacy should continue.Artemisinin-containing combination therapies (ACTs) are now being deployed in some 42 malaria endemic countries and a further 26 have agreed to adopt ACTs following the World Health Organization (WHO) recommendation that ACTs should be the first line drugs for treating uncomplicated falciparum malaria (data provided by WHO/GMP, February 2007).Artesunate plus amodiaquine (AS+AQ) is one of the currently available ACTs and is in use in Indonesia and 18 African countries (Burundi, Cameroon, Congo, C?te d'Ivoire, Democratic Republic of Congo, Equatorial Guinea, Gabon, Ghana, Guinea, Liberia, Madagascar, Malawi, Mauritania, Senegal, Sao Tome & Principe, Sierra Leone, Sudan (South), Zanzibar).Because the WHO policy change is recent, there is, to date, little experience with the systematic u
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