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NCT ID: NCT02497612 Terminated - Clinical trials for Plasmodium Falciparum Infection

To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

FALCI
Start date: July 25, 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children. Secondary Objectives: - To evaluate the efficacy of OZ439/FQ: - To determine the incidence of recrudescence and re-infection. - To determine the time to relief of fever and parasite clearance. - To evaluate the safety and tolerability of OZ439/FQ in adults and children. - To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood. - To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.

NCT ID: NCT02435524 Completed - Breast Feeding Clinical Trials

Alive & Thrive Evaluation in Burkina Faso

Start date: June 2015
Phase: N/A
Study type: Interventional

The time between birth and age 24 months provides a unique opportunity to impact the long-term health and development of children through improved infant and young child feeding practices. In Burkina Faso, the prevalence of exclusive breastfeeding is currently around 25% in infants younger than six months. The purpose of this study is to evaluate whether the Alive & Thrive intervention package, consisting of interpersonal counselling and community mobilisation activities, can increase the exclusive breastfeeding rate among infants younger than six months to at least 50% using a cluster randomised design.

NCT ID: NCT02415933 Completed - Child Abuse Clinical Trials

Child Protective Outcomes Among Ultra-poor Families in Burkina Faso

Start date: October 2014
Phase: N/A
Study type: Interventional

This study tests the effects of family-based economic empowerment intervention, alone and in combination with child rights sensitization component, on child protective outcomes among ultra-poor families in Nord Region, Burkina Faso.

NCT ID: NCT02374450 Completed - Malaria Clinical Trials

A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine

Start date: October 5, 2015
Phase:
Study type: Observational

The purpose of this pre-licensure cohort study is to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan African children under 5 years of age. The outcomes of this study will provide the baseline data for the post-licensure EPI-MALARIA-003 (115056) study that will evaluate the safety, effectiveness and impact of the RTS,S/AS01E vaccine. An interim analysis was performed on a sub-group of study participants enrolled in active surveillance from sites where the vaccine is currently implemented, having 6 months of follow-up following the administration of dose 3 of DTP/HepB/Hib vaccine (6-12 weeks group), or 6 months after Visit 3 (mimicking the RTS,S/AS01E primary vaccination schedule) for the 5-17 months group; corresponding to Visit 5. The interim analysis concerned primary safety endpoints and the main secondary endpoints.

NCT ID: NCT02341469 Completed - IMCI Guidelines Clinical Trials

A Trial of an Integrated E-diagnosis Assessment to Improve the Management of Childhood Illnesses in Burkina Faso

IeDA
Start date: September 2014
Phase: N/A
Study type: Interventional

In 2010, one in six children in Burkina Faso died before the age of five, mainly due to lack of access to quality health care services. Most of these deaths could have been avoided through cost-effective interventions. Ensuring that sick children receive adequate care in a country where 80% of the population lives in rural areas requires improved accessibility and high quality primary health care services. The Integrated Management of Childhood Illnesses strategy (IMCI) was developed by the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) in the 1990s and is an excellent way to improve the quality of country's child health services. However, in Burkina Faso IMCI suffers from a low level of adherence by health workers. According to a recent evaluation by the Ministry of Health (MoH), only 8.2% of children had benefited in 2012 from an consultation using IMCI guideline. Moreover, an analysis of children's records showed that only 15% of IMCI consultations were being correctly delivered and, for instance, only 34% of children with pneumonia who needed an antibiotic were prescribed the correct treatment. The obstacles to IMCI adoption in Burkina Faso are diverse and include inadequate training methods, shortage of material (papers, forms), lack of quality supervision by district executive teams, lack of integration between IMCI monitoring tools and the national health information system etc. The Integrated eDiagnosis Approach (IeDA) aims to address the poor quality of child health services in Burkina Faso by increasing the level of adherence to IMCI guidelines. IeDA is an innovative strategy combining information and communication technologies (using the Registre Electronique des Consultations [REC], an electronic IMCI patient record designed by Terre des hommes, Tdh) and a quality improvement approach. The approach has been piloted over three years in two different districts in the north of Burkina Faso, Tougan and Séguénéga. This medium scaling-up demonstration project will combine implementation and research components with a goal to enable national scaleup. Terre des hommes is in charge of the implementation of the project and the London School of Hygiene and Tropical Medicine (LSHTM) will coordinate the research component of the study in partnership with Centre Muraz. The primary hypothesis is that the Integrated eDiagnosis Approach will lead to improved adherence to IMCI guidelines and management of childhood illnesses in two regions (with a target of 75% of correct diagnoses and prescriptions).

NCT ID: NCT02309489 Completed - Postpartum Period Clinical Trials

Involving Men in Maternity Care in Burkina Faso

Start date: January 2015
Phase: N/A
Study type: Interventional

The uptake of postpartum contraception, postpartum care attendance and the practice of exclusive breastfeeding are low in Sub-Saharan Africa. Although the involvement of men in maternity care has been shown to be a promising strategy for the achievement of other reproductive health goals, little is known about the effect of their participation on these outcomes. This study aims to test whether the involvement of men can improve care-seeking and promote healthy behaviours among postpartum women in Burkina Faso.

NCT ID: NCT02251704 Recruiting - Malaria Clinical Trials

Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Start date: October 22, 2014
Phase: Phase 4
Study type: Interventional

This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003 studies, enrolling from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. The co-primary objectives are to produce longitudinal estimates of parasite prevalence in humans, and record malaria control measures usage in areas where EPI-MAL-002 and EPI-MAL-003 studies will take place.

NCT ID: NCT02245152 Completed - Clinical trials for Child Acute Malnutrition

The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Burkina Faso: a Cluster Randomized Intervention Study

PROMIS-BF
Start date: October 6, 2014
Phase: Phase 4
Study type: Interventional

Globally, child undernutrition is the underlying cause for 3.1 million deaths of children younger than 5 years. 18.7 million children under five years of age suffer from severe acute malnutrition (SAM) and an additional 33 million children suffer from moderate acute malnutrition, and are at risk of developing SAM In Sub-Saharan Africa, there is often poor integration between programs to treat child acute malnutrition and programs that focus on the prevention of acute and chronic undernutrition - resulting in many missed opportunities for using prevention platforms to screen and refer SAM children, or for using screening and referral platforms to provide prevention services. This project will address two critical gaps related to the integration of preventive and treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically integrated into routine health-center visits or mainstreamed into community outreach programs; and 2) screening programs often do not offer any preventive services for those children found not to be suffering from MAM/SAM at the time of screening; mothers of children identified as non-MAM/SAM case are usually sent home without receiving any health or nutrition inputs and as a result, may fail to come back for screening because they do not see any tangible benefit associated with their participation in the screening. This project will specifically address these gaps by assessing the effect of an integrated approach consisting of higher screening coverage and preventive Behavior Change Communication (BCC) + Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment of child undernutrition.

NCT ID: NCT02236468 Completed - Anemia Clinical Trials

Creating Homestead Agriculture for Nutrition and Gender Equity (CHANGE) in Burkina Faso

CHANGE
Start date: March 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the long-term impact of the Enhanced Homestead Food Production Program implemented by HKI on household food security and nutritional status, as well as the impact on including additional interventions (BCC on WASH and malaria prevention, distribution of preventive lipid-based nutrient supplements (LNS)) to children aged 6-24 months old, in addition to the standard E-HFP model.

NCT ID: NCT02211729 Completed - Malaria Clinical Trials

A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children

SMCAZ
Start date: May 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether addition of azithromycin (AZ) to Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine (AQ) will provide an additional reduction in deaths and severe illness in young African children. The secondary objectives include an assessment of the safety and cost-effectiveness of the addition of AZ to SMC with SP+AQ. This a double blind, randomised, placebo controlled trial. The unit of randomisation will be the household. Children aged 3 - 59 months will be randomised to receive four cycles of either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission season. Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59 months of age at the start of each period of drug administration will be eligible for inclusion in the trial provided that parental consent is obtained. Children with a severe, chronic illness or known allergy to one of the study drugs will be excluded. Primary endpoint: Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period Secondary endpoints: 1. incidence of the primary endpoint during the whole study period 2. attendance at a study health centre with a nonmalaria febrile illness 3. attendance at a study health centre with malaria, 4. the prevalence of moderate anaemia at the end of each malaria transmission season, 5. nutritional status at the end of each malaria transmission season, 6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant pneumococci before and at the end of each malaria transmissions season, 7. prevalence of resistance markers to SP at the end of the study, Sample size: 19,200 children (9600 in each country) will be enrolled.