Cohort event monitoring of patients treated for uncomplicated malaria with artemisinin-based combination therapies in selected hospitals and community pharmacies in Nigeria.

AIMS AND OBJECTIVES: The study was designed with the broad objective of determining the safety profile of artemisinin-based combination therapies amongst Nigerian population. PATIENTS AND METHODS: This was a cohort event monitoring (CEM) programme involving monitoring adverse events (AEs) in malaria patients treated with either artemether-lumefantrine (AL) or artesunate-amodiaquine (AA) in healthcare facilities in Nigeria. The study involved continuous enrolment of patients with malaria and treated with either AL or AA at the various sites until a total cohort of 600 patients were enrolled at each site. Patients were monitored from the onset of therapy, and on days 3 and 7 from the first day of treatment to identify AEs that may occur. RESULTS: A total of 6102 AEs were recorded in 10,259 patients monitored during the programme. Of 4896 patients who received AA, 4233 (86.5%) patients reported at least one AE while 1869 (34.8%) AEs out of 5363 patients who received AL were reported (P = 0.010). The predominant incidence of each specific AE reported in each group among the patients who received AA and AL includes body weakness 30.8%/7.5%, dizziness 10.3%/3.9%, restlessness 5.02/1.12%, vomiting 3.5/1.03% and drowsiness 3.1/1.5% for AA and AL, respectively. There were more AEs among patients with co-morbid conditions and patients in the younger age groups (9-<15 years), P = 0.000. CONCLUSIONS: Various types of AEs were seen and documented during the CEM programme. The findings suggested that the AA/AL monitored during this programme was generally safe and remarkably well tolerated among the Nigerian populations.

Intermittent preventive treatment during pregnancy with sulphadoxine-pyrimethamine may promote Plasmodium falciparum gametocytogenesis.

OBJECTIVES: To determine the incidence of gametocytes and the propensity of sulphadoxine-pyrimethamine to promote gametocytogenesis when used as intermittent preventive treatment in pregnancy. SUBJECTS AND METHODS: This observational non-interventional study assessed the influence of intermittent preventive treatment with sulphadoxine-pyrimethamine on Plasmodium falciparum gametocytaemia among Nigerian pregnant women. A total of 306 pregnant women were enrolled in the study. RESULTS: The 306 pregnant women had 711 events, of which 31 pure gametocytaemic episodes were documented and 27 were recorded among the intermittent preventive treatment users. Only 4 episodes of pure gametocytaemia were recorded in pregnant women who did not receive any dose of sulphadoxine-pyrimethamine (27/129 vs. 4/276, χ(2) = 15.9, p = 0.00006). CONCLUSION: Our findings show that intermittent preventive treatment in pregnancy with sulphadoxine-pyrimethamine may predispose to gametocyte carriage in pregnant women resident in the hyperendemic malaria region of southwest Nigeria. We therefore suggest that the use of insecticide-treated nets be encouraged among pregnant women resident in malaria-endemic sub-Saharan Africa in order to reduce malaria transmission.

Comparative study of efficacy of artesunate plus cotrimoxazole and artesunate plus chloroquine in the treatment of malaria in Nigerian children: a preliminary report.

BACKGROUND & OBJECTIVES: The study was undertaken to evaluate the efficacy of cotrimoxazole plus artesunate and to compare the efficacy of this combination with that of artesunate plus chloroquine in the treatment of acute uncomplicated falciparum malaria in children. METHODS: Children aged between 0.5 and 12 yr with clinical and parasitological evidence of Plasmodium falciparum malaria were randomized to receive either artesunate plus cotrimoxazole or artesunate plus chloroquine. They were followed-up with clinical and parasitological assessment for a period of 14 days. RESULTS: In all, 57 out of 81 (31 in the artesunate plus cotrimoxazole group and 26 in artesunate plus chloroquine group) completed the study as per protocol and were evaluated. Pre-treatment clinical and parasitological parameters were similar in the two treatment groups. The time to clear fever and other symptoms were similar in the two groups 1.0 +/- 0 vs 1.14 +/- 0.38 (p > 0.05). Parasite clearance times were also similar; 1.65 +/- 0.49 days vs 1.58 +/- 0.67 days respectively for artesunate plus cotrimoxazole and artesunate plus chloroquine (p > 0.05). The cure rates on Day 14 were 100% for both artesunate plus cotrimoxazole and artesunate plus chloroquine groups. Both drug combinations were well-tolerated in the small population of children. CONCLUSION: These results indicate that artesunate plus cotrimoxazole has similar efficacy to artesunate plus chloroquine in the treatment of acute uncomplicated P. falciparum malaria in children resident in an endemic area of south-west Nigeria.

Malaria: passive case detection and healthcare providers' choices of chemotherapy.

Prompt diagnosis and treatment play a central role in the malaria control programme in sub Saharan Africa. However, in most cases the diagnoses are never confirmed either for lack of facility or disinterest of healthcare providers resulting in over-diagnosis. To determine the proportion of clinically diagnosed malaria cases who could be confirmed with microscopy and evaluate compliance of healthcare providers with the National treatment guidelines for malaria. Participants were patients referred for malaria microscopy after the attending physicians had made clinical diagnosis of malaria. Thick blood smears were made under strict asepsis, stained and thereafter examined under oil immersion objective lens. Of the 630 patients who were referred with clinical impression of malaria, only 224 or 35.6% were positive for malaria parasite. The slide positive patients were younger with a mean age of 10.6 +/- 13.0 years versus 17.2 +/- 18.5 years [P < 0.005] for the slide negative individuals. There were only few instances of non-compliance with the National treatment guidelines for malaria. In conclusion, there appears to be over-diagnosis of malaria considering that only about a third of the clinical malaria cases were confirmed by microscopy. There is need for large epidemiological studies and possible policy review.

Impacts of Seasonal Malaria Chemoprevention on Malaria Burden among under Five-Year-Old Children in Borno State, Nigeria.

Malaria disproportionately affects all ages with a high burden among children below five years. Thus, control measures are deployed including Seasonal Malaria Chemoprevention (SMC). The present study assessed the impacts of SMC on malaria burden among subjects aged 3-59 months in Borno State, Nigeria. Twenty (20) clusters were randomly selected from accessible 16 Local Government Areas (LGAs) of Borno State, Nigeria, and SMC was deployed in 10 of the clusters by administering a full dose of amodiaquine plus sulfadoxine-pyrimethamine at monthly intervals for 4 months consecutively. Three hundred and ninety-nine children were enrolled in the study. A structured questionnaire was used to obtain demographic and malaria-related data. Thick blood smear, thin blood smear, and capillary sample were collected two weeks after the 4th cycle of SMC. The prevalence of malaria and anaemia was determined among the subjects and for the clusters. The proportions of the female (46.4%; 185/399) and male (53.6%; 214/399) subjects were similar (p > 0.05) with subjects aged 24-47 months (35.8%; 143/399) accounting for the highest proportion (p < 0.05). Malaria prevalence was 10.3% (41/399) and was higher among non-SMC subjects (15.9%; 31/195) than among SMC subjects (4.9%; 10/204) (p < 0.05, df = 1, χ 2 = 10.8). Malaria prevalence was higher in non-SMC clusters (80.0%; 8/10) than in SMC clusters (30.0%; 3/10) (p < 0.05, df = 1, χ 2 = 40.5). The mean haematocrit of the 399 subjects was 34.0 ± 5.3% with an anaemia prevalence of 18.1% (72/399). The mean haematocrit was higher among SMC subjects (35.4 ± 5.0% vs. 33.1 ± 4.2%; p < 0.05) while anaemia prevalence was higher among non-SMC subjects (21.5% vs. 14.6%; p < 0.05, df = 1, χ 2 = 2.8). Of the SMC subjects, 4.9% reported adverse drug reactions. SMC is safe and significantly reduced malaria burden among children in Borno State, and thus, the measure could be deployed in the state for effective malaria control.

Predictors of asymptomatic malaria in pregnancy.

A number of studies have described malaria parasitaemia in pregnancy as mostly an asymptomatic condition, however information about predictors of asymptomatic malaria is largely lacking. We investigated the prevalence of symptoms and potential predictors of asymptomatic malaria in pregnant women attending Ante-Natal Clinic (ANC) of two public maternity hospitals in Ibadan, Southwest-Nigeria. Demographic data, history of previous and present pregnancy were obtained from the subjects and blood smears were examined for malaria diagnosis by light microscopy. Seventy - seven parasitaemic pregnant women attending antenatal clinic were evaluated for presence or absence of symptoms that may be associated with malaria. Thirty-seven women (48%) were asymptomatic whereas 40 (52%) presented with symptoms such as weakness, headache and general body ache and fever. Parasite density was significantly higher in symptomatic patients (P = 0.042), while asymptomatic patients had low level parasitaemia but significantly higher gametocyte carriage (P = 0.035). In conclusion, parasitaemic pregnant women resident in hyper- or holo-endemic malaria region are likely to be symptomatic with increasing density of the parasitaemia.

Asexual and sexual stages of Plasmodium falciparum in Nigerian pregnant women attending antenatal booking clinic.

Susceptibility to infection by Plasmodium falciparum is increased in pregnant women. In sub-Saharan Africa, the consequences of maternal malaria include preterm birth, fetal growth restriction and increased infant mortality. Malaria transmission requires the circulation of viable gametocytes that can be ingested by the female mosquito taking a blood meal. This study was conducted to evaluate the presence of asexual and sexual stages of P. falciparum in pregnant women attending antenatal booking clinics in south-western Nigeria, an area hyper-endemic for malaria. Gametocyte carriage was about 13%, similar to that documented for children symptomatic for malaria in our area of study.