There are about 249 clinical studies being (or have been) conducted in Ghana. 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.
Schistosomiasis and soil-transmitted helminhtiasis occur throughout the developing world and are most prevalent in the poorest communitites. These worms have been linked to several nutritional and intellectual deficiencies in many endemic populations worldwide. Helminth control, though crucial has been neglected for varied reasons. Currently, interests towards the control of neglected diseases including schistosomiasis and soil-transmitted helminths has been revived through many interventions including repeated chemotherapy to help improve public health outcomes and prevent long term morbidity. This will contribute to achieving several of the Millennium Development Goals at a favourable cost. A community-directed treatment of human schistosomiasis and STH in school-aged children in rural notrhern Ghana using praziquantel and albendazole is proposed. It is planned to test the hypothesis that community-based volunteers are non-inferior and more cost effective than rural school teachers at reaching school-aged children.
This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first dose, when co-administered with other EPI vaccine antigens. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Among the best practices recommended for malaria control during pregnancy is ensuring effective case management of malaria illness. However, this is often not practiced because (1) malaria infection in pregnancy is often asymptomatic, (2) peripheral parasitaemia may be absent even when the placenta is heavily parasitized, (3) implementing diagnosis and treatment of malaria within a routine antenatal service may be difficult and (4) antimalarial treatment options available to pregnant women are limited due to resistance to chloroquine(CQ) and sulfadoxine-pyrimethamine(SP0 and paucity of safety and efficacy data on other antimalarial drugs in pregnancy, particularly artemisinin combination treatments (ACT). Therefore the commonest recommended practice in pregnancy is the administration of SP as intermittent preventive treatment (SP-IPTp). However, the effectiveness of SP-IPTp has been questioned because parasite resistance to SP is spreading rapidly across sub-Saharan Africa. This is a three-arm open label randomised control non-inferiority trial of insecticide-treated nets(ITN) plus rapid diagnostic test(RDT) screening, and treatment with SP or amodiaquine plus artimisinin(AQ+AS) versus ITN plus IPTp using SP. It is to be carried out in pregnant women of all parities presenting at enrolling antenatal clinics with a gestation of 16 to 20 weeks at their first booking. The key objectives are to demonstrate that (1) the prevalence of severe anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation (2) the prevalence of low birth weight (BW < 2500g) at delivery or within 72 hours after delivery (3) the prevalence of placenta parasitaemia and (4) the incidence of serious and non-serious adverse events in the ITN plus RDT screening and treatment arm are not greater than those in the ITN plus IPTp arm. Alongside the clinical assessments, health care cost assessments will be done to determine the cost-effectiveness of the two delivery strategies measured as cases of severe maternal anaemia averted.
The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.
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.
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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.
This study, conducted at Korle-Bu Hospital in Accra, Ghana, will help elucidate the roles of lifestyle and genetic factors in prostate cancer risk. There is a strong variation in risk of prostate cancer throughout the world. The rates of the disease among African Americans are some of the world s highest. In the United States, the incidence of prostate cancer is 70 percent higher in African Americans than in white Americans and the death rate in African Americans is almost double that of white Americans. The reasons for this excessive risk are unknown, but both genetic and lifestyle factors have been suggested. Because Africans and African Americans share similar genetic ancestry but have vastly different lifestyles, a better understanding of the rates and risk factor profiles for prostate cancer among Africans will provide important clues to what causes the disease. This study will try to assess the incidence of prostate cancer in the West African nation of Ghana. The study has two components: - Clinical survey The methods of diagnosis at Korle-Bu will be evaluated and the incidence of prostate cancer over a 5-year period will be estimated. - Screening and detection survey A survey of 1,000 men between 50 and 74 years of age will estimate the prevalence of both asymptomatic and undiagnosed symptomatic prostate cancer in the Accra population. The clinical survey will use data from the cancer logbook and medical records at Korle-Bu Hospital and the Ghanaian National Census to derive an estimate of prostate cancer incidence within Accra. The estimate will be low, since it will be based only on men diagnosed or treated at Korle-Bu and will not include men with asymptomatic disease, men diagnosed elsewhere, or men without access to medical care. The screening and detection survey will assess the presence of asymptomatic and unrecognized symptomatic prostate cancer using PSA testing and digital rectal examination in a random sample of 1,000 men in the general population of Accra. This will provide a high estimate of disease prevalence. The two estimates will provide an approximation of the true incidence rate of the disease in Accra. Comparison of these data with similar data from community surveys of African Americans will provide insight into reasons for the excess risk of prostate cancer in African Americans.
The standard for treatment Buruli ulcer disease (BUD) used to be surgery but the WHO now advises streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily) along with surgery. This preliminary advice was based on observations in 21 patients with pre-ulcerative lesions of BUD, who were given daily SR treatment for varying periods of time. In patients treated with SR for at least 4 weeks, M. ulcerans could no longer be cultured from excised lesions. SR has been introduced without a formal evaluation or comparison with other treatments have been conducted or published, but the impression is that this treatment is beneficial and may cure BUD without additional surgical management. This study protocol evaluated the hypothesis that early, limited lesions of BUD(pre-ulcerative or ulcerated lesions, ≤ 10 cm maximum diameter), can be healed without recurrence using antimycobacterial drug therapy, without the need for debridement surgery. In endemic regions in Ghana, patients will be actively recruited and followed if ≥ 5 years of age, and with early (i.e., onset < 6 months) BUD. - consent by patients and / or care givers / legal representatives - clinical evaluation, and by - analysis of three 0.3 cm punch biopsies under local anaesthesia. - disease confirmation: dry reagent-based polymerase chain reaction (DRB-PCR IS2404) - randomization: either SR for 8 weeks, or 4 weeks of SR followed by R and clarithromycin (C) - stratification: ulcerative or pre-ulcerative lesions. Biopsies processed for histopathology, DRB-PCR-, microscopy, culture, genomic, and sensitivity tests. Lesions assessed regularly for progression or healing during treatment. Drug toxicity monitoring included blood cell counts, liver enzymes and renal tests; and ECG and audiographic tests. Primary endpoint: healing without recurrence at 12 months follow-up after start of treatment Secondary endpoint: reduction in lesion surface area and/or clinically assessed improvement on completion of treatment, averting the need for debridement surgery. Recurrences biopsied for confirmation, using PCR, histopathology, and culture. Sample size calculation: 2x74 fully evaluable patients; 80% power to detect a difference of 20 % in recurrence-free cure 12 months after start of treatment between the two groups (60 versus 80%). A Data Safety and Monitoring Board made interim analysis assessments.