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NCT ID: NCT04816461 Not yet recruiting - Malaria Clinical Trials

Boosting the Impact of SMC Through Simultaneous Screening and Treatment of Roommates

SMC-RST
Start date: July 2021
Phase: Phase 4
Study type: Interventional

Malaria represents a major public health concern in sub-Sahara Africa. Seasonal malaria chemoprevention (SMC) is one of the largest preventive measures. It consists to administer Amodiaquine+Sulfadoxine-Pyrimethamine to children aged 3-59 months on a monthly basis during the peak malaria transmission season. Despite its implementation, the burden of malaria is still very high in children under five years old in Burkina Faso. This raises questions about other hidden factors that can negatively affect the effectiveness of SMC intervention. Huge effort aiming at preventing human-vector contact were deployed such as the large-scale distribution of insecticide treated bed nets. Healthy humans are only infected via mosquitos if there are parasites reservoir around. Yet, there is no strategy aiming at protecting healthy humans from parasites reservoir. Under these circumstances, multiples humans sharing the same habitat could continually entertain the transmission cycle despite adequate existing measures. This would obviously jeopardize the expected impact of the SMC and the global effort to control the disease. In such context, we postulate that screening and treating malaria SMC-children's roommates could greatly improve the impact of SMC intervention and reduce malaria transmission in endemic settings. The goal of our study is to improve the impact of SMC intervention in terms of reducing malaria morbidity and mortality in children under five years. Primary objectives include assessing whether SMC + children's roommates screening and treatment with Dihydro-artemisinin-piperaquine (DHAPPQ) is more effective than current routine implementation of SMC alone as well as the assessment of the tolerance and safety of AQSP and DHAPPQ. Secondary objectives include the assessment of the impact of the new strategy on the circulating parasite population in terms of selection of resistant strains and the assessment of determinants such as adherence and acceptability of the strategy. Methodology: The study will be carried out in the Nanoro health district catchment area in Burkina Faso. This will be a randomized superiority trial. The unit of randomization will be the household and all eligible children from a household will be allocated to the same study group to avoid confusion. Households with 3 - 59 months old children will be assigned to either (i) control group (SMC alone) or (ii) intervention (SMC+ roommates screening with standard HRP2-RDT and treatment if positive) or (iii) intervention (SMC+ roommates screening with highly sensitive RDT and treatment if positive). The sample size will be 789 isolated households per arm, i.e. around 1,578 children under CPS coverage and 2,630 roommates expected. They will be followed-up for 24 months to fully cover two consecutive malaria transmission seasons and then two SMC cycles. Children will be actively followed-up during the malaria transmission seasons while in the dry seasons the followed-up will be passive. Conclusion: The project will respond to a major public health concern by providing evidence of the efficacy of a new strategy which should necessarily complement the existing ones to achieve best impact in malaria control and elimination. The project is lifesaving and could be scaled up easily at country and regional level in case of promising results. In addition, if successful, the project will reinforce the capacity of the IRSS/CRUN by offering training opportunities to young researchers.

NCT ID: NCT04778813 Not yet recruiting - Malaria Clinical Trials

Evaluation of Three Artemisinin-based Combinations for the Treatment of Uncomplicated Malaria in Childreen in Burkina Faso (CHIMIO2)

CHIMIO2
Start date: June 1, 2021
Phase: Phase 4
Study type: Interventional

Bakground In Burkina Faso, since the adoption of this new malaria treatment policy in 2005, several studies evaluating the efficacy and tolerance of ACTs have been carried out by different research teams at different sites according to an irregular chronology and according to different methods. Studies conducted in children 6 to 59 months with supervised use of ACTs indicate adequate clinical and parasitological response rates varying between 93% to 98% after correction to the PCR at day 28. With the introduction of seasonal malaria chemoprevention (SMC) by the Sulfadoxine-Pyriméthamime/amodiaquine combination in almost all health districts of Burkina Faso, ASAQ is no longer recommended for the treatment of uncomplicated malaria in the areas covered by this intervention. In 2017, DHA-PPQ was added to the national treatment guidelines as a first-line treatment option. The therapeutic efficacy study carried out in 2017-2018 by the CNRFP showed a PCR-corrected treatment failure rate of over 10% with the AL combination. However, molecular analyzes have not shown the presence of mutations at position 580 on the PfK-13 gene which is associated with resistance to artemisinin derivatives. The combination artesunate-pyronaridine (As-Pyr) was recently added to the WHO Prequalified Medicines List and Essential Medicines List. In 2019, it received regulatory marketing authorization to be used as a treatment for malaria in Burkina Faso. Burkina Faso (along with the Niangoloko and Bobo Dioulasso centers) was one of the countries where clinical trials p ar the As-Pyr association were led. This combination has been found to be effective and well tolerated in Burkina Faso. The combinations of AL and DHA-PPQ were observed to be well tolerated in previous efficacy studies. The combinations DHA-PPQ and As-Pyr could potentially replace AL as first-line treatment in Burkina Faso if the results of these planned therapeutic efficacy studies continue to show a high rate of failures with AL. The herein study aims to assess the efficacy and safety of AL, DHA-PPQ and As-Pyr in the treatment of uncomplicated malaria in children in three health districts in Burkina Faso, namely the health districts of Banfora, Nanoro and de Gourcy. This study will provide PNLP and the Ministry of Health with additional data and evidence on the safety and efficacy of these treatments against malaria in Burkina Faso. Primary objective The primary objective is to assess the clinical and parasitological efficacy of AL, DHA-PPQ and AS-Pyr in the treatment of uncomplicated P. falciparum malaria in children aged 6 months to 12 years, corrected by PCR on day 28 (AL) or 42 (DHA-PPQ & AS-Pyr). Study settings The study will be conducted at the medical center (CMA of Niangoloko, the Clinical Research Unit of Nanoro (URCN) and the medical center with surgical antenna (CMA) of Gourcy. Populations Febrile patients of both sexes aged between 6 months and 12 years with confirmed uncomplicated P. falciparum mono-infestation who wellcome for an outpatient visit to the health facilities. Procedures It will be a multicenter, randomized, open-label, three-arm study involving three sites representing the three epidemiological facies of malaria in Burkina Faso. The three therapeutic combinations (AL, DHA-PPQ and As-Pyr) will be tested in different sites with different characteristics of transmission and resistance of malaria. Children with uncomplicated malaria who meet the criteria for inclusion in the study will be recruited and treated with the combination of AL or DHA-PPQ or As-Pyr. They will be monitored for 28 days for the AL group and 42 days for the DHA-PPQ and AS-Pyr arm. The follow-up will consist of scheduled control visits during which clinical examinations and laboratory tests will be carried out. A total of 1050 children will be enrolled in the study. Main results 1. The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or adequate clinical and parasitological response. 2. The frequency and nature of adverse events. 3. The blood concentration of lumefantrine on day 7

NCT ID: NCT04716712 Not yet recruiting - Child Mortality Clinical Trials

Infant Mortality Reduction by the Mass Administration of Azithromycin

MIRAMA
Start date: June 1, 2021
Phase: Phase 4
Study type: Interventional

This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.

NCT ID: NCT04695197 Recruiting - Covid-19 Clinical Trials

Malaria as a Risk Factor for COVID-19 in Western Kenya and Burkina Faso

MALCOV
Start date: January 8, 2021
Phase: Phase 3
Study type: Interventional

It is unknown whether malaria or malaria treatment affects COVID-19 severity, immune responses to SARS-CoV-2 virus, or viral loads and/or duration of shedding and therewith the onwards spread of SARS-COV-2. An observational cohort study will be conducted in 708 newly diagnosed COVID-19 patient of all ages in western Kenya and Burkina-Faso. They will be enrolled in hospitals with COVID-19 testing facilities from a source population screened for SARS-CoV-2 (N~4,720). Approximately 142 of the 708 COVID-19 patients are expected to be co-infected with malaria. They will be enrolled in the nested malaria treatment trial and randomized to receive 3-days of artemether-lumefantrine (the current standard of care) or pyronaridine-artesunate, a highly effective antimalarial with known antiviral properties against SARS-CoV-2 in-vitro, that is newly registered and being rolled out in Africa. Disease progression will be assessed and nasal swabs and blood samples will be taken during home/clinic visits on days 1, 3, 7, 14, 21, 28, and 42. Patients self-isolating will be phoned daily in between scheduled visits for the first 14 days to assess signs and symptoms. Hospitalisation, self-isolation and home-based care will follow national guidelines. The WHO clinical progression scale and FLU-PRO plus scales will be used to compare disease progression between COVID-19 patients with and without malaria, and by malaria. Other endpoints include seroconversion/reversion rates, chemokine/cytokine responses, T and B cell responses, viral load and duration of viral carriage. Infection prevention and control (IPC), including the use of personal protection equipment (PPE), and measures for patient transport will follow national guidelines in each country. Written informed consent/assent will be sought. The study is anticipated to start in January 2021 and last for approximately 18 months.

NCT ID: NCT04657640 Recruiting - Anemia Clinical Trials

School-Based Assessment of Micronutrient Interventions in Adolescents in Burkina Faso

SAMIA
Start date: December 11, 2020
Phase: Phase 3
Study type: Interventional

This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status, school performance/attendance and development outcomes among adolescents in Burkina Faso.

NCT ID: NCT04650815 Recruiting - Malaria Clinical Trials

Malaria Transmission in Humans and Mosquitoes at the Area of Sabou, Burkina Faso

Start date: April 23, 2021
Phase:
Study type: Observational

Background: Malaria is a disease that affects many people in Burkina Faso. It is caused by germs that are spread by mosquito bites. A vaccine that blocks the spread of malaria is important to get rid of the disease. To see if a vaccine works, researchers need to find out how many malaria infections are happening in the community. Objective: To learn how often people of all ages who live in Sabou, Burkina Faso, get malaria. Eligibility: Healthy people ages 6 months to 65 years who reside in Sabou in a household with adults and children. Design: Participants will be screened with questions about their health. They will have a physical exam. Participants will be asked about any malaria symptoms they are having. They will be asked about the use of bed nets. Their vital signs, like blood pressure and temperature, will be measured. They will have blood taken from their arm with a needle. Participants who have a fever will have a malaria test. Those who test positive for malaria will be referred to the local health facility for treatment. Participants will have monthly study visits. Blood will be taken from a finger. Participants may be invited to take part in 2 mosquito feeding experiments. Mosquitos that do not carry malaria will bite their arm. And a small amount of blood will be fed to mosquitos in a laboratory. Participants' homes will be examined for mosquitoes. Researchers will remove all mosquitoes they collect. Participants' homes will be sprayed with a chemical to kill mosquitoes and other insects. Participation will last for 12 months.

NCT ID: NCT04601714 Recruiting - Malaria Clinical Trials

Baseline Cohort Malaria Morbidity Study

BLOOMy
Start date: September 7, 2020
Phase:
Study type: Observational

The BLOOMy study is a longitudinal prospective cohort study of healthy children to assess the incidence of clinical malaria over the main transmission season. Participants will undergo baseline clinical and biological assessments then will receive a curative dose of either artesunate or dihydroartemisinin-piperaquine to clear any existing parasitemia. Clearance of parasites will be confirmed 3 weeks later by Polymerase chain reaction (PCR) and only participants with negative PCR will be definitively enrolled for the longitudinal follow up. Both active and passive case detection will be used to ensure that capture of a high proportion of infections in the cohort is achieved. Blood samples for immunological assessments will be obtained at Day 0 of each positive blood smear episode before treatment and at Weeks 4 post treatment. Participants will be followed for a minimum of six months throughout the malaria peak transmission season.

NCT ID: NCT04582474 Recruiting - Dengue Clinical Trials

Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso

Start date: September 10, 2020
Phase: N/A
Study type: Interventional

The Integrated Management of Childhood Illness (IMCI) guideline has been implemented in Burkina Faso and is used across primary health facilities to assess children under the age of 5 years. A part from a rapid diagnostic test (RDT) for malaria, no other point of care in vitro diagnostic tests are widely used to improve disease diagnosis and inform treatment decisions. Dengue fever has been reported in Burkina Faso since 1925 and the recent epidemics in 2016 and 2017 have prompted the government to validate and deploy a clinical management algorithm for Dengue and a case reporting process to support surveillance for a targeted response. The organisation Terre des hommes has digitalised IMCI and implemented the module through its Integrated electronic Diagnosis Approach (IeDA) programme across primary health care centers (PHCs) in the country with proven impact on clinical care and proven reduction in antibiotic prescriptions. Many recognize the need to update the IMCI guideline with current evidence. However this is challenging and may require large clinical trials. The advantage of electronic clinical decision support systems is plural: they improve quality of care through increased adherence and feedback information to the system; they strengthen surveillance systems by connecting relevant patient related data and provide geo-tagged coordinates for targeted responses; and they can become evidence-adaptive. An electronic module of the Burkina Faso Dengue clinical management guideline accompanied with dengue rapid diagnostic tests has the potential to improve the diagnosis of non-malaria fevers in particular during "dengue seasons" and improve the efficiency of surveillance for this disease. In this study, the investigators aim to assess the usability and the performance of the dengue module for patient management in primary health care facilities.

NCT ID: NCT04545905 Recruiting - Malaria Clinical Trials

Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso

Start date: September 22, 2020
Phase:
Study type: Observational

Burkina Faso will be deploying next-generation ITNs through mass campaigns in pre-determined provinces. As part of New Nets Project's initiative to catalyze the market introduction of next-generation ITNs, enhanced surveillance activities will be conducted to support observational impact analyses. As part of this enhanced surveillance, malaria infection prevalence is being measured through annual cross-sectional surveys during peak transmission periods using rapid diagnostic tests (RDTs) in children aged 6 to 59 months (under 5 years). It will also include strengthened routine data collection at all health facilities in the districts. The present study aims to leverage the planned cross-sectional surveys and strengthened routine data conducted by the New Nets Project in three of the study districts (Banfora, Gaoua, and Orodara) to assess (1) whether the malaria infection prevalence data collected during antenatal care (ANC) surveillance correlates with these estimates of community infection prevalence in children 6 to 59 months and (2) if intervention coverage data (particularly ITN ownership and use) collected from ANC surveillance are valid and representative of the population as a whole. These additional data could catalyze a new model of surveillance for malaria, and greatly simplify evaluation of the impact of new interventions, as ANC surveillance could potentially replace or supplement cross-sectional household surveys and provide more granular and timely data. All pregnant women attending first ANC visit at seven health facilities in each study district and who are 20 years old or older or in a union will be eligible for enrollment. Potential participants will be approached during their visit by a health facility worker. During group counselling sessions at initial intake, women will be informed of this pilot surveillance activity, and written informed consent will be obtained from each woman individually prior to routine ANC testing. All consenting women attending ANC first visit at a participating health facilities will be tested for malaria using an RDT and asked to complete a study questionnaire which will include questions about the participant's net use, and care seeking behavior. It is expected to take 15 minutes to complete. Women who test positive for malaria will be given treatment according to national guidelines. There is no additional benefit to individual participants. The specific objectives of this ANC surveillance pilot are to: 1. Determine the prevalence of malaria infection and coverage of malaria control interventions among pregnant women attending their first ANC visit. 2. Assess the correlation between ANC surveillance parasite prevalence from this study, malaria incidence measured from health facilities, and parasite prevalence collected by the New Nets Project during cross-sectional household surveys. 3. Analyze the correlation between health seeking and net use/access in the ANC surveillance and health seeking behavior compared to the cross-sectional survey

NCT ID: NCT04445441 Completed - Clinical trials for Coronavirus Infection

An Observational Study to Assess the Protocol for the COVID-19 Treatment in Burkina Faso

CHLORAZ
Start date: April 24, 2020
Phase:
Study type: Observational

This is an observational study to evaluate the effectiveness of the combinations Hydroxychloroquine + Azithromycin (HCQ-AZ) and Chloroquine + Azithromycin (CQ-AZ) in the treatment of Coronavirus (Covid-19) infection in Burkina Faso.