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NCT ID: NCT00852423 Completed - Clinical trials for Malaria in Pregnancy

Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria

PREGACT
Start date: June 2010
Phase: Phase 3
Study type: Interventional

Malaria is the most important human parasitic disease and is responsible of high morbidity and mortality in resource-poor countries. Pregnant women, who are a high-risk group, are almost always excluded from clinical trials; thus, the investigators lack sufficient information on the safety and efficacy of most antimalarials in pregnancy. The recommendation of the World Health Organization to use artemisinin combination therapy (ACT) in the 2nd and 3rd trimester is already implemented in several African countries, however documentation of their efficacy and safety in pregnancy is still limited. Thus, the investigators propose to evaluate the efficacy and safety of 4 ACT(artemether-lumefantrine, amodiaquine-artesunate, mefloquine-artesunate and dihydroartemisinin-piperaquine), when used to treat pregnant women with P. falciparum malaria; the results will help to recommend the optimal therapy for this high-risk group in Africa.

NCT ID: NCT00832754 Completed - Malaria Clinical Trials

Restricting the Use of Artesunate Plus Amodiaquine Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial

RDT-ACT
Start date: March 2009
Phase: Phase 4
Study type: Interventional

Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT) depends on the accuracy and safety of RDT based treatment practices and on factors related to the health delivery system. We propose to study the accuracy and safety of RDT based diagnosis and treatment of febrile illness, health system determinants of effective use of RDTs and the public health outcomes of RDT based ACT for malaria.A cluster randomised trial of RDT based versus clinical judgment based treatment of febrile illness on the incidence of malaria in <48 month old children will be conducted. Health Centres will be randomly allocated to RDT based treatment or clinical judgment based treatment arm and children under 2years of age from the catchment area of each health centre will be followed for 2 years. The cost effectiveness of RDT based approach will be compare with the clinical judgement based treatment.

NCT ID: NCT00814411 Completed - Contraception Clinical Trials

A Trial of Group Versus Individual Family Planning Counseling in Ghana

GCFP
Start date: June 2008
Phase: Phase 3
Study type: Interventional

This study uses a randomized, noninferiority design to determine whether group family planning counseling is as effective as individual family planning counseling among gynecological patients with unmet need at two teaching hospitals in Ghana.

NCT ID: NCT00790998 Completed - Onchocerciasis Clinical Trials

Study Comparing Moxidectin And Ivermectin In Subjects With Onchocerca Volvulus Infection

Start date: April 2009
Phase: Phase 3
Study type: Interventional

This is a Phase 3 study comparing the efficacy, safety and tolerability of moxidectin and ivermectin in subjects infected with Onchocerca volvulus, which is the parasite that causes river blindness. Subjects participating in the study will be randomly assigned (by a 2 to1 ratio) to receive one orally-administered dose of either moxidectin or ivermectin.

NCT ID: NCT00720811 Completed - Malaria Clinical Trials

Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

Start date: October 2009
Phase: N/A
Study type: Interventional

This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. In one arm the children will be treated presumptively for malaria with ACT (control arm) and the other arm the children will receive ACT only when they have a positive RDT result (implementation arm). The children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. The primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on Day 3. In addition, an acceptability assessment of RDTs in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to demonstrate comparable levels of endemicity in control and intervention groups. These activities will be carried out over a two year period.

NCT ID: NCT00677833 Completed - Malaria, Falciparum Clinical Trials

Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

Start date: June 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.

NCT ID: NCT00623337 Completed - Neonatal Mortality Clinical Trials

Ghana Newborn Home Visits Neonatal Mortality Trial

Newhints
Start date: January 2009
Phase: Phase 3
Study type: Interventional

Introduction: Just under four million infants die each year before reaching one month of age; neonatal deaths now account for 38% of the 10.8 million deaths among children younger than 5 years of age. Tackling neonatal mortality is essential if the millennium development goal to reduce by 2015 overall child mortality by two-thirds from its levels in 1990 is to be achieved. Postnatal care for mothers and neonates in developing countries, particularly when deliveries occur at home, is either not available or is of poor quality. Trained community workers are considered by many to be pivotal to newborn care in the community, as they can act as catalysts for community actions and also be providers of care.Reductions in neonatal mortality have been slower in Sub-Saharan Africa than in any other region, and no evaluations of the effectiveness and feasibility of home visits in reducing neonatal mortality have been conducted. Trial aim: To link with the Ghana Health Service to develop a feasible and sustainable intervention to improve newborn care practices and careseeking during pregnancy and childbirth, and to identify and refer very low birth weight and/or sick babies, through routine home-visits by community health workers (CHWs), and by so doing reduce neonatal mortality.

NCT ID: NCT00550160 Completed - Malaria Clinical Trials

The Synergistic Effects of Home-management and Intermittent Preventive Treatment of Malaria in Children

KNUST-COMDIS
Start date: April 2007
Phase: Phase 4
Study type: Interventional

This cluster randomised trial is proposed to assess the clinical impact of adding a seasonal intermittent preventive treatment (IPTc) schedule for children aged 3 -59 months to a home management of malaria (HMM) programme using AQ+AS in Ghana. The study will be conducted in the Kwaso sub district of the Ejisu-Juaben district of Ghana in which 6 communities will be randomised to implement an IPTc schedule alongside the HMM programme or HMM programme alone. The study will run in three phases; a preparatory phase to set up and obtain baseline morbidity data from a cross-sectional survey; an intervention phase and a post intervention phase of cross-sectional survey and data evaluation and dissemination. A cohort of 546 study children randomly selected will receive three full treatment courses of AS+AQ intermittently during the April - Nov 2007 transmission season. Community-based drug distributors (CDDs) will administer all courses of IPTc. The first dose of each course will be directly observed by the CDDs who will educate mothers or caregivers to administer subsequent doses appropriately at home. Follow up visits to homes will be done by CDDs and field supervisors to ascertain adherence and to monitor adverse drug events. The incidence of clinical malaria and other secondary outcomes will be compared with those of another cohort of 546 study children who will not receive IPTc but may be treated under the HMM strategy alone with AS+AQ when necessary during the observation period.

NCT ID: NCT00499876 Completed - HIV Infections Clinical Trials

The Effect of Malaria on Disease Progression of HIV/AIDS

Start date: October 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to find out whether malaria affects how HIV/AIDS disease progresses in an infected patient, and to determine the effect of reducing malaria infection on HIV disease progression in Kumasi

NCT ID: NCT00493922 Completed - Malaria Clinical Trials

Trial of Rapid Diagnostic Tests in Rural Ghana

RDT
Start date: July 2007
Phase: Phase 4
Study type: Interventional

1) To compare in a setting where microscopy for malaria is available whether introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v clinical diagnosis).