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NCT ID: NCT05650502 Completed - Clinical trials for Immune System Disease

Impact of Seasonal Malaria Chemoprevention on Immunity Against Malaria Among Children in Northern Benin

Start date: June 1, 2021
Study type: Observational [Patient Registry]

This study aims to evaluate the effects of SMC (Seasonal malaria chemoprevention) with Sulfadoxine-Pyrimethamine (SP) and Amodiaquine (AQ) on the evolution of anti-malarial immunity of children and their susceptibility to malarial infection. This is a cross-sectional study on children aged 6 to 59 months with/without SMC in two villages in northern Benin. Sociodemographic and clinical data as well as repeated blood samples will be collected from 440 children (before, during and after treatment). Samples will be analyzed using a Luminex assay to investigate antibody responses to MSP (merozoite surface protein) , Glurp (Glutamate-Rich Protein) and a panel of PfEMP1. qPCR (quantitative polymerase chain reaction) will be used to detect the prevalence of malaria at this period and parasites infecting children will be characterize during the follow up.

NCT ID: NCT05423847 Recruiting - Tuberculosis Clinical Trials

Triage UltraSound in Tb Endemic Regions

Start date: October 14, 2021
Study type: Observational

In Sub-Saharan Africa, lower respiratory tract infections (LRTIs) and tuberculosis (TB) jointly are the leading cause of overall mortality. There is a need to integrate sustainable triage and management strategies into standard care. The TrUST study investigates the utility of point-of-care ultrasound (POCUS) for diagnosis and prognosis of LRTIs in TB endemic regions in the outpatient triage setting. Automated interpretation of POCUS by artificial intelligence (AI) may further standardize and improve its predictive utility as well as facilitate its implementation into usual practice.

NCT ID: NCT05169554 Recruiting - Buruli Ulcer Clinical Trials

Beta-Lactam Containing Regimen for the Shortening of Buruli Ulcer Disease Therapy

Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

Buruli ulcer (BU) is a skin Neglected Tropical Disease (NTD) that is caused by Mycobacterium ulcerans. It affects skin, soft tissues and bones causing long-term morbidity, stigma and disability. The greatest burden falls on children in sub-Saharan Africa. Treating BU requires 8-weeks with daily rifampicin and clarithromycin, wound care, and sometimes tissue grafting and surgery. Healing can take up to one year. Compliance is challenging due to socioeconomic determinants and may pose an unbearable financial burden to the household. Recent studies led by members of this Consortium demonstrated that beta-lactams combined with rifampicin and clarithromycin are synergistic against M. ulcerans in vitro. Amoxicillin/clavulanate is oral, suitable for treatment in adults and children, and readily available with an established clinical pedigree. Its inclusion in a triple oral BU therapy has the potential of improving healing and shortening BU therapy. The investigators propose a single blinded, randomized, controlled open label non-inferiority phase II, multi-centre trial in Benin with participants stratified according to BU category lesions and randomized in two oral regimens: (i) Standard [RC8]: rifampicin plus clarithromycin (RC) therapy for 8 weeks; and (ii) Investigational [RCA4]: standard (RC) plus amoxicillin/clavulanate (A) for 4 weeks. At least, a total of 140 patients will be recruited (70 per treatment arm), of which at least 132 will be PCR-confirmed. The primary efficacy outcome will be lesion healing without recurrence and without excision surgery 12 months after start of treatment (i.e. cure). A clinical expert panel assessing the need of excision surgery in both treatment arms will be blinded for treatment allocation in order to make objectives comparisons. Decision for excision surgery will be delayed to 14 weeks after initiation of antibiotic treatment. Secondary clinical efficacy outcomes include recurrence, treatment discontinuation and compliance rates, and the incidence of adverse effects, among others. In addition, two sub-studies will be performed: a pharmacokinetic (PK) analysis and a bacterial clearance study. If successful, this study will create a new paradigm for BU treatment, which could inform changes in WHO policy and practice. This trial may also provide information on treatment shortening strategies for other mycobacterial infections, such as tuberculosis or leprosy.

NCT ID: NCT04528823 Recruiting - Latent Tuberculosis Clinical Trials

GXT - GeneXpert or Chest-X-ray or Tuberculin Skin Testing for Household Contact Assessment

Start date: January 31, 2020
Phase: N/A
Study type: Interventional

The objective of the study is to compare outcomes from three different strategies for the management of household (HH) contacts of individuals with newly diagnosed microbiologically confirmed active pulmonary TB. The study is a cluster randomized trial with three arms of equal size. The first eligible member of the HH who provides signed informed consent to participate will be randomized to one of the three strategies. The three different study arms are as follows: 1. Standard care (control arm): Participants will receive symptom screening and tuberculin skin testing (TST). If symptom screen positive and/or TST positive, they undergo chest x-rays (CXR). If CXR abnormal, they undergo microbiological investigation. If CXR normal or if microbiological investigation negative, TST positive receive latent TB infection (LTBI) treatment. If microbiological investigation is positive, they will be offered treatment for active TB. For children under 5 years of age in Brazil, sputum induction will be performed for bacteriological investigation 2. GeneXpert (GX): Participants follow an algorithm similar to the standard care, however participants with positive symptom screen and/or positive TST will receive GX (i.e., GX replaces CXR in standard care algorithm). GX positive are considered to have active TB. TST positive and GX negative receive LTBI treatment. If an individual is not able to provide sputum, they will undergo a CXR. 3. CXR for all/NoTST: Participants will receive symptom screening and CXR. No TST will be performed. If CXR abnormal or symptom positive, they undergo microbiological investigation. If the CXR is normal, and/or microbiological investigations negative - they receive LTBI treatment as per national guidelines. If microbiological investigation is positive they will be offered treatment for active TB. The study population includes HIV uninfected persons aged 5-50 years who are HH contacts of individuals with newly diagnosed microbiologically confirmed active pulmonary TB. The planned number of household contacts to recruit is about 1434 in total, or about 455 for each of the three arms. The study will take place in Benin and Brazil. The primary study outcome is, of those eligible for LTBI therapy, the proportion starting therapy within 3 months of the index TB patient starting active TB treatment. Secondary outcomes measured in each study arm include societal costs, prevalence of microbiologically confirmed and clinically diagnosed active TB, prevalence of TB infection, Incidence of adverse events, proportion who complete LTBI therapy, sensitivity and specificity of Chest Xray reading in each study side, and prevalence of active TB diagnosed using CXR in participants who cannot produce a sputum sample. Details of the statistical analysis plan for each primary and secondary outcome are provided below. Applicable for Brazil only: To evaluate the applicability and performance of material for bacteriological investigation obtained from induced sputum in children under 5 years of age. Study participants will be recruited over 18 months. Participants will be followed until LTBI treatment is completed.

NCT ID: NCT04303507 Completed - COVID19 Clinical Trials

Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting

Start date: April 29, 2020
Phase: N/A
Study type: Interventional

The study is a double-blind, randomised, placebo-controlled trial that will be conducted primarily in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other persons at risk of contracting COVID-19, who can be followed reliably for 5 months. The initial aim was to recruit 40,000 participants and we predict an average of 400-800 participants per site in 50-100 sites. The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months. If the participant is diagnosed with COVID-19, they will take continue to take the study medication until: - 90 days after enrolment (i.e., completion of kit) - hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or - advised to stop by their healthcare professional for other reasons Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period. This study is funded by Wellcome Trust Grant reference 221307/Z/20/Z.

NCT ID: NCT03931473 Active, not recruiting - Anemia Clinical Trials

Efficacy of Two Dual Active Ingredient Long Lasting Insecticidal Nets for Control of Malaria Transmitted by Pyrethroid Resistant Vectors in Benin

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors. New types of LLIN combining a mixture of two insecticides have been developed to control resistant mosquitoes. The efficacy of two bi-treated LLIN are compared to a standard LLIN in a three-arm, single blinded, cluster-randomized trial in Cove, Benin. The arms are; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and fertility of eggs, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, LLIN incorporating a mixture of two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ The control arm: Interceptor, a standard LLIN treated with alpha-cypermethrin. The primary outcome of the trial will be malaria case incidence in children aged 6 months to 10 years.

NCT ID: NCT03660839 Completed - Clinical trials for Plasmodium Falciparum Infection

Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria

Start date: September 11, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) for the effect and the area under the curve (AUC) of OZ439 as pharmacokinetic (PK) predictor. Secondary Objectives: - To evaluate the exposure-response of OZ439 combined with FQ on crude Day 28 ACPR. - To evaluate the dose response of OZ439 combined with FQ on PCR-corrected and crude Day 28 ACPR. - To evaluate the dose-response of OZ439 combined with FQ on selected secondary endpoints. - To evaluate the safety and tolerability of different dosages of OZ439 in combination with FQ and FQ alone. - To characterize the PK of OZ439 in plasma, and of FQ and its active metabolite SSR97213 in blood.

NCT ID: NCT03303963 Active, not recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

DIAgnostics for Multidrug Resistant Tuberculosis in Africa

Start date: May 4, 2017
Study type: Observational

Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin Resistant Tuberculosis (RR-TB) but only rifampicin resistance is diagnosed, leading to presumptive diagnosis of resistance to isoniazid and maybe other drugs. Thus in low and middle income countries, most drug sensitivity testing relies on phenotypic drug resistance testing, which takes up to 4 months. In addition, currently, culture on monthly sputum samples is recommended by the World Health Organization for follow-up of Rifampicin Resistant Tuberculosis patients under treatment. Unfortunately, culture is often not locally available and samples need to be transported from field to culture laboratories. The associated transport delays lead to high rates of contamination and false negative culture, particularly in laboratories in low resource settings. Many gaps for the diagnosis and management of RR-TB patients still need to be addressed and the DIAMA project (DIAgnostics for Multidrug resistant tuberculosis in Africa) study aims to address some of them.

NCT ID: NCT03231449 Active, not recruiting - Stroke Clinical Trials

A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa

Start date: February 1, 2017
Study type: Observational

FEVRIER study is an observatory of hospitalizations in cardiology units in sub-Saharan Africa.

NCT ID: NCT03044899 Completed - Surgery Clinical Trials

African Surgical Outcomes Study (ASOS)

Start date: February 1, 2016
Phase: N/A
Study type: Observational [Patient Registry]

STUDY OBJECTIVE To confirm the incidence of in-hospital postoperative complications in adult surgical patients in Africa. STUDY DESIGN Seven day, African national multi-centre prospective observational cohort study of adult (≥18 years) patients undergoing surgery. Patients will be followed up for a maximum of 30 days. We will follow the original International Surgical Outcomes Study (ISOS) study design. The primary outcome is in-hospital postoperative complications in adult surgical patients in Africa. Secondary outcomes include in-hospital mortality and the relationship between postoperative complications and postoperative mortality. The intention is to present a representative sample of surgical outcomes across all African countries. This study will run between February and March 2016.