There are about 211 clinical studies being (or have been) conducted in Burkina Faso. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations (ACT) [amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate] for single and repeat treatments of uncomplicated malaria in children. Safety will be determined by registering adverse events and grading, laboratory, and vital signs evaluations. Their incidence will be compared between the different study arms. TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities. The leading EC approved the amendment on 2nd June 2008. TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.
CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria. The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has already been shown to be efficacious against P.falciparum in adults and children in Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any parasites escaping treatment over the 3-day course. The addition of artesunate is also anticipated to have the population benefit of protection against the development of resistant strains of P.falciparum, although it will not be possible to demonstrate this in a clinical trial. One further population benefit of the artemisinin drugs are their ability to suppress the sexual forms of the parasite (gametocytes), which should reduce infectivity after antimalarial treatment and potentially lower transmission rates with widespread use, including the spread of any parasites resistant to the partner drug. The aims of this phase III study are to compare the efficacy of a fixed ratio combination tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and adults, with chlorproguanil-dapsone as a comparator.
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ.
Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's Medicines and Healthcare products Regulatory Agency. CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a treatment for acute uncomplicated P. falciparum malaria. The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supersede chlorproguanil-dapsone for the same indication, but the addition of an artemisinin derivative, artesunate, should provide additional population benefits over chlorproguanil-dapsone alone. The artemisinins have been demonstrated to rapidly reduce parasite load and have activity against the sexual stages of the P.falciparum lifecycle. The addition of a second agent to the chlorproguanil-dapsone combination should also protect against the selection of resistant strains of P.falciparum. Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination Therapy actually available and is considered as the gold standard for the treatment of P. falciparum malaria. This study will therefore aim to demonstrate the non-inferiority of the combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days. The key secondary objectives will compare the Parasite Clearance Times (PCT) and the Fever Clearance Times (FCT) between CDA and artemether-lumefantrine.
There is increasing evidence from African countries, including Burkina Faso, that at least in some settings/seasons the proportion of fevers attributable to malaria is low or very low: this means that the current strategy of treating all fever cases as malaria is only to the advantage of very few. Rapid, antigenic tests might be of help, particularly in peripheral health centres such as the "Centres de Santé et Promotion Sociale" (CSPS) that lack any laboratory facilities. Nevertheless two major problems could arise: - False negatives: as only the negative result would change the decision to treat, versus the current "presumptive" strategy, false negatives would not be treated for malaria. - False positives: they would be exposed to the risk to be left without treatment for the true cause of their fever instead. The main purpose of this study is to assess if the short term outcome of febrile patients treated after testing with the Rapid Diagnostic Test Paracheck® is at least equivalent (not inferior) to that of controls (presumptively treated without any test) in terms of clearance of fever and other major symptoms and signs. To do so, febrile patients will be randomly assigned to be submitted to the test before clinical decision, or to be managed the usual way with no test. A follow up will be carried out at Day 4th in order to determine the proportion of patients in both groups with persistence of fever and other main clinical symptoms.
Design: Single-centre Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN). Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital outpatient department. Sample size: N=120 Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three days (first and second day: 10mg/kg, third day: 5mg/kg). Statistical procedures: The primary analysis parameter is the proportion of clinical failures on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without PCR correction), the rate of early clinical failures, the rate of late parasitological failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the overall group of study children and for rural (n=50) and urban (n=50) study children separately. Study duration and dates: The study will be implemented in September-December 2005.
Insecticide-impregnated bed nets and curtains (ITN) have been shown to be effective against malaria. However, given that most ITN studies were of limited length, researchers have postulated the hypothesis that in areas of intense malaria transmission and due to possible interactions with immunity development, ITN interventions may cause no effect at all or even a long-term increase in malaria morbidity and mortality. The overall objective of the trial is to analyse the long-term effects of ITN on child morbidity and mortality in an area of intense malaria transmission. The specific objective is to analyse if there is a difference in the rates of malaria morbidity and mortality as well as in all-cause mortality in children being protected with ITNs from birth compared to children protected with ITNs from age 6 months onwards. The study is conducted in the Nouna Health District, in Burkina Faso, and specifically in a sub-portion of the District under demographic surveillance since 1999. The sub-portion of the District under demographic surveillance includes a total population of 70 000 individuals, distributed in 42 villages and in the town of Nouna. The region is a dry Savannah characterised by high levels of malaria transmission. The study design entails a prospective community-based trial, with newborn children being identified at the village level and then individually randomised to receive either intervention A or intervention B. Intervention A is defined as ITN protection from age 0 to 59 months (i.e. protection from birth). Intervention B is defined as ITN protection from age 6 to 59 months (i.e. protection from 6 months onwards). Enrollment in the study cohort in continued until the sample size is reached (n = 2 600, 1 300 group A and 1 300 group B). Detailed data on morbidity is collected through means of a prospective follow up on a sub-sample of 420 children from 6 sentinel villages (210 from group A and 210 from group B). These 420 children are visited daily by field workers who measure their temperature. In case of fever, field workers take a blood sample through finger prick to be analysed for malaria parasitaemia. Treatment free of charge is organised for all children in this subsample. In addition, these children are visited twice a year for the collection of clinical (malaria episodes, anaemia) and parasitological (rates of malaria parasitaemia, parasite density) parameters. Data collection on this subsample of children is meant to last from June 2000 to December 2003. For study purposes, falciparum malaria is defined as 37.5 C or more plus at least 5 000 parasites per micro-litre. All-cause mortality in the overall study sample (2 600 children) are ascertained through means of a demographic surveillance system (DSS), which regularly monitors deaths (as well as births and migration) in the region. The causes of death are identified through means of verbal autopsy. All children enrolled in the study are followed up through means of the DSS from birth up to 5 years of age. The primary study outcome will be the five-year all-cause mortality in the total number of children enrolled in the study (2 600). Secondary outcomes will be the study of malaria-specific mortality, clinical parameters, and parasitological parameters in a sub-sample of the study cohort (420).
Attempts to understand the relationship malaria transmission intensity and antimalarial drug resistance had rested mainly on mathematical models. To date, except for two studies which reported reductions in the prevalence of drug resistance in Tanzania and Zimbabwe, no other field data addressed the impact of reducing malaria transmission by the use of vector control measures on antimalarial drug resistance. Thus whether vector control decrease or increase drug resistance remains a contentious issue. The aim of this study was to investigate the impact of insecticide-treated curtains (ITCs) on clinical and parasitological outcomes in children with uncomplicated malaria treated with chloroquine (CQ), on the prevalence of genetic markers of resistance to CQ and sulphadoxine-pyrimethamine (SP) and on the ability of children to clear drug resistant parasites. The therapeutic efficacy of CQ was studied in 9 villages which used ITCs for 6-8 years and 9 villages with no history of ITC use. A cross-sectional survey was also conducted to estimate the prevalence of genetic markers of resistance to CQ and SP in asymptomatic children.
Genital herpes is a long-life sexually transmitted diseases which infects a large proportion of women in Africa. Its clinical symptoms are painful sores on the genitals, which heals after a few days. HIV infection can worsen genital herpes. In turn, it is possible that genital herpes increases the quantity of HIV secreted at the genital level in women infected by the 2 viruses. This study is dedicated to verify this hypothesis.