There are about 33 clinical studies being (or have been) conducted in Niger. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes. The investigators hypothesize that door-to-door delivery will have higher coverage and costs and similar feasibility and acceptability compared to fixed-point delivery.
Acute malnutrition (AM) is a continuum condition, arbitrarily divided into severe and moderate categories (SAM, MAM) which are managed separately, with programs overseen by different agencies with different products and supply chains. Such separation complicates delivery of care, contributes to poor program performance, and creates confusion among caregivers. Reduction in the mortality burden from AM will stem from improved simplicity, efficiency and cost-effectiveness of current protocols. Eligibility for SAM treatment in the current Niger protocol is complex. It is determined by 3 independent criteria: nutritional oedema, Mid-Upper Arm Circumference (MUAC) < 115 mm or weight-height Z score (WHZ) <-3. Also, the Ready to Use Therapeutic Food (RUTF) ration in Niger protocol (130-200 kcal/kg/d) is paradoxical. The amount of RUTF prescribed in the first weeks of treatment is often less than what given to child reaching recovery (MUAC > 125 and WHZ >-2), because weekly ration is determined by the child's weight. Rate of weight gain is highest in the first two weeks of treatment, then plateaus - suggesting no benefit of increased RUTF ration at the end of treatment. Progressive reduction is a more rational use of RUTF and this supplement is equally effective for SAM and MAM. This community-based non-inferiority trial will compare two strategies for the treatment of AM to the Niger protocol for SAM and MAM. The Optimizing treatment for acute MAlnutrition (OptiMA) strategy uses MUAC < 125 mm or nutritional oedema as admission criteria and optimizes RUTF by adapting doses to the degree of malnutrition. RUTF dose for MUAC < 115 mm or oedema is 170 kcal/kg/d and progressively reduces to 75 kcal/kg/d as MUAC increases. The Combined Protocol for Acute Malnutrition Study (ComPAS) uses the same eligibility criteria like OptiMA, but simplifies more the RUTF ration by providing 1000 kcal/d for children with oedema or MUAC < 115 mm and 500 kg/d for children with MUAC 115-124 mm. Children are considered recovered if they have 2 consecutive weekly MUAC measures ≥ 125 mm. Children will be individually randomized to treatment in one of the 3 study arms and will attend clinic visits weekly until nutritional recovery. After discharged, they will be monitored monthly via a nurse-conducted home visits until 6 months post-inclusion. The trial arms will be compared using a composite outcome indicator that includes vital status, anthropometric measures and relapse following the index AM episode. The hypothesis is that simplified strategies could substantially increase the number of children in care compared to current SAM programs without requiring additional RUTF or staffing while maintaining recovery rates in line with current programs.
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.
To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).
The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings.Targeting treatment to children 1-11 months old could reduce antimicrobial resistance by limiting antibiotic distributions while treating children at the highest mortality risk. However, this targeted intervention has not yet been tested. The AVENIR mortality/resistance trial aims to assess the efficacy of age-based targeting of biannual azithromycin distribution on mortality as well as determine the impact of age-based targeting on antimicrobial resistance.
The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maradi, Niger. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.
A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine+amodiaquine (AL+AQ) and artesunate-mefloquine+piperaquine (ASMQ+PPQ) and the ACTs artemether-lumefantrine+placebo (AL+PBO), artesunate-mefloquine+placebo (ASMQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.
The aim of this open-label randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic and Senegal) is to compare three strategies of renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. Cognitive development of children (Senegal) will also be studied and compared.
The trial is an interventional, cluster-randomized trial to assess the impact of oral ciprofloxacin for household and community contacts of meningitis cases on the incidence of meningitis during an epidemic. The trial contains a nested sub-study ("resistance study") to assess the effect of a single dose of ciprofloxacin on the prevalence of fluoroquinolone-resistant enterobacteriaceae in the study area.
MORDOR was a cluster-randomized placebo controlled trial that assessed the efficacy of mass azithromycin distributions for the prevention of childhood mortality. All communities were subsequently treated with mass azithromycin for one year. The present trial re-randomized communities to azithromycin or placebo for the fourth and fifth year of the study.