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NCT ID: NCT05689047 Not yet recruiting - Acute Malaria Clinical Trials

Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

Start date: January 23, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria. Pyramax (Artesunate/Pyronaridine) will act as an internal control providing reference safety data and a benchmark for the efficacy evaluation.

NCT ID: NCT05588752 Not yet recruiting - Clinical trials for Caesarean Section; Pain

Transverse Abdominal Plane Block for Caesarean

Start date: October 20, 2022
Phase: N/A
Study type: Interventional

Cesarean sectionis a commonly performed major surgical procedure that results in significant postoperative pain. The objective of this study was to evaluate the effectiveness in the management of post-cesarean pain at the CHU Souro Sanou of Bobo-Dioulasso

NCT ID: NCT05586139 Not yet recruiting - Clinical trials for Acute Malnutrition in Childhood

Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition

MDF
Start date: January 16, 2023
Phase: N/A
Study type: Interventional

The goal of this experimental study is to test the efficacy of a new formulation - The microbiome-directed food (MDF) to treat acute malnutrition among children aged 6 to 23 months. The main questions it aims to answer are: - Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher programmatic recovery rate compared to standard of care ? - Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher sustained recovery rate compared to standard of care ? The MDF will be compared to Ready-to-use supplementary food (RUSF) and a locally available food (LAF) for moderately malnourished children, and to Ready-to-use therapeutic food (RUTF) for severely malnourished children to see the effects on recovery and sustained recovery rate.

NCT ID: NCT05535465 Recruiting - Malaria Clinical Trials

Malaria Control : Improving Access to Prevention, Diagnostic and Care for Vulnerable Rural Communities

REACT-2
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

In the REACT 2 project, a consortium proposes to study in Burkina Faso and Côte d'Ivoire, the impact of a public health intervention in rural communities in order to improve access to malaria therapeutic and preventive arsenal for vulnerable populations (i.e. children, adolescents and pregnant women). The intervention relies on the implementation of mobile health workers to support community health workers.

NCT ID: NCT05478954 Recruiting - Malaria Clinical Trials

Chemoprevention Efficacy Study in Burkina Faso

Start date: July 15, 2022
Phase: Phase 4
Study type: Interventional

The aim of this study is to determine whether Seasonal Malaria Chemoprevention (SMC) remains effective in the health district of Nanoro in the Centre-Ouest region or Boussé in the Plateau Central region. It also aims to assess the protective efficacy of the antimalarial drugs used in SMC in the target population and to investigate levels of parasite resistance in the study districts. According to the results, this trial should provide the evidence needed to change the drugs used in SMC. A Type II hybrid effectiveness-implementation study design will be used to evaluate the effects of a clinical intervention on relevant outcomes whilst collecting information on implementation. It is designed to determine feasibility and effectiveness of an innovative intervention, as well as the protective efficacy of the antimalarial drugs used. The study consists of two components: 1) Conducting a prospective cohort study to determine the protective efficacy of the drug combination Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) (if SPAQ provides 28 days of protection from infection) and whether drug concentrations and/or resistance influence the duration of protection; 2) Conducting a resistance markers study in symptomatic patients in the research district.

NCT ID: NCT05426187 Recruiting - Clinical trials for Malaria in Pregnancy

Follow-up of Immunological Pattern and Pregnancy Outcomes in Women Previously Received Placental Malaria Vaccine

PRIMVACLongT
Start date: February 18, 2022
Phase:
Study type: Observational

Study Population: Participants of the previous PRIMVAC vaccine trial and women aged 18 to 35 years Sample Size: 90 Study duration: 21 months Subject duration: 12 months if pregnancy doesn't occurred. In case of pregnancy, the participant will be followed up until the delivery. Study Design: Long term observational study comparing the immunology trend of 3 groups of i) women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso; ii) women of the same age and nulligravid who did not participate in the phase 1b trial iii) women of the same age and primigravid who did not participate in the phase 1b trial Co Primary objectives - To assess the dynamics of humoral immune response to the vaccine antigen during long term follow up of the study participants - To evaluate the functional durability of the humoral immune responses of women who participated in the phase 1b vaccine trial compared to women of the same age Secondary objectives - To assess the cellular immune response during the follow-up period - To assess the incidence of clinical malaria on study participants - To assess the prevalence of Placental Malaria in study participants and adverse outcomes such as maternal anemia, low birth weight, stillbirth and prematurity.

NCT ID: NCT05405322 Recruiting - HIV Infections Clinical Trials

Improving Care and Community Representation for Adolescents and Young Adults Living With HIV in West Africa

TRANSITIONS
Start date: April 7, 2021
Phase:
Study type: Observational

Context: HIV-positive young people aged 15 to 24 are a heterogeneous population in terms of gender, age, mode of transmission, sexual orientation and risk-taking. This most vulnerable age group is at greater risk of disruption of medical care and poor compliance, and has greater needs for psychosocial support and differentiated health services. It remains highly invisible in West African countries, both in the definition of care policies and in the allocation of resources and community representation. Objectives: The overall objective of the project is to contribute to the improvement of retention in care, health and well-being of adolescents and young adults living with HIV (AYAHIV) and to support their integration into the community space. SO1: Support the operationalisation of the transition of HIV-infected adolescents from paediatrics to adult medical services in a stakeholder inclusive, participatory and responsive approach SO2: Contribute to the empowerment and autonomy of adolescents and young adults living with HIV in the project environment SO3: Contribute to the generation and dissemination of evidence-based information and recommendations on the situation and needs of adolescents and young adults, including key populations, living with HIV Target: Approximately 67 caregivers∙e∙s ≥ 25 years old, of which 64%F, 30 peer-referent associations of 20-24 years old (ratio F/H= 1:1), 700 AYAHIV ≥ 15 years old, of which 47%F, in paediatrics and 500-600 AYAHIV aged 15-24 years old in adult medicine, of which 41%F, and including AYAHIV associations Summary of activities: Based on the capitalisation and pooling of experiences of partner teams, the project proposes to support the implementation of transition in a pragmatic approach, adapted to the needs of adolescents and inclusive of carers, adolescents and community peers. More globally, it contributes to improving the health, empowerment and autonomy of HIV-positive youth, including key populations, in particular through support to training, structuring and community representation of youth associations, documentation of the conditions of entry into care and their specific needs, including digital health, production and availability of evidence and recommendations in this West African context and advocacy building. A multidisciplinary and participatory research-action project, carried out by the IRD in Senegal and financed by Sidaction, accompanies the three specific objectives of the project.

NCT ID: NCT05396664 Recruiting - Clinical trials for Adolescent Development

Adolescent Transition West Africa

ATWA
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This trial will serve as an outcome evaluation of 'Adolescent Transition in West Africa' (ATWA), a school-based program in Mali, Burkina Faso, and Niger for adolescents ages 10-19. The overall objectives of the project are as follows: Impact: Improved sexual and reproductive health and rights of 472,180 adolescents. Outcome 1: Improved sexual and reproductive health and rights and gender equality knowledge, intent, and behaviors among 472,180 adolescents. Outcome 2: 500 health facilities offer quality adolescent responsive SRH services that are used by adolescent girls and boys. To evaluate program impact, an external evaluation will be conducted. A pre/post cross-sectional evaluation design will be used across two evaluation years.

NCT ID: NCT05378880 Enrolling by invitation - Clinical trials for Antimicrobial Stewardship

Optimising Community Antibiotic Use and Infection Control With Behavioural Interventions in Burkina Faso and DR Congo

CABU-B/C
Start date: May 18, 2022
Phase: N/A
Study type: Interventional

Emergence of antibiotic resistance (AMR) is a serious concern for Low and Middle Income Countries (LMICs). Unregulated use of antibiotics, a major AMR driver, is highly prevalent in LMICs, with medicine stores as key providers. Physical interactions between One Health compartments increase cross-domain transmission risks, although the relative importance of different reservoirs is uncertain, with community-level dynamics of AMR in LMICs largely unquantified. In two rural health districts in Burkina Faso and DR Congo, a behavioural intervention bundle will be developed, targeting medicine stores and their communities, to optimise antibiotic use and improve hygiene, and hence reduce AMR prevalence and transmission. After a 6-month local co-development phase, the intervention will be implemented over 12 months and evaluated through a comparison between intervention and control clusters, consisting of one or more villages or neighbourhoods largely seeking healthcare with the same provider(s). The primary outcome measure is the change in Watch antibiotic provision from medicine stores (where a formal prescription is not required), assessed via patient exit interviews and simulated client visits. Changes in hygiene practices and AMR pathogen and gene carriage will be assessed in repeated population surveys. Rodents, living in close proximity to humans in much of sub-Sahara Africa, provide a proxy estimate of environmental AMR pathogen and gene exposure. Using modelling and sequencing of selected isolates, impact of AMR transmission by changes in antibiotic use and hygiene practices will be quantified.

NCT ID: NCT05335395 Not yet recruiting - Child Development Clinical Trials

SUNRISE CRT: Radio Intervention to Stimulate Early Child Development

SUNRISE
Start date: April 2022
Phase: N/A
Study type: Interventional

SUNRISE aims to develop and evaluate a radio campaign to promote nurturing care behaviours in the first 3 years of life, particularly responsive parenting and providing opportunities for early learning. The campaign will be broadcast by local radio stations in Burkina Faso for 3 years and comprise: 60-second radio 'spots' including scripted dramas and modelling of responsive parent-child interactions, broadcast 10 times a day in weekly cycles; plus long format evening programs 2-3 times/week, incorporating longer dramas, real life testimonials and practical 'how to' advice, with space for listeners to call in, express opinions and ask questions. The campaign's impact on early child development (ECD) will be evaluated using a cluster RCT design, alongside a process and health economic evaluation.