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NCT ID: NCT03073707 Completed - Clinical trials for Salmonella Infections

Reservoir of Invasive Salmonellosis in Children, DRC

Start date: January 2017
Phase: N/A
Study type: Observational

Bloodstream infections caused by non-typhoid Salmonella (NTS) are a major killing disease in Sub-Saharan Africa. Despite the high case fatality rate, the main reservoir -human, zoonotic or environmental- for invasive NTS rests unknown. The main objective of this study is to assess 1. the household environment (household member, cattle and pets, rats) for intestinal carriage of NTS and 2. the household water supply for presence of NTS . Households of children with proven NTS invasive infection will be addressed.

NCT ID: NCT03048669 Recruiting - HIV/AIDS Clinical Trials

Long Term Outcomes of Therapy in Women Initiated on Lifelong ART Because of Pregnancy in DR Congo

Start date: November 2016
Phase: N/A
Study type: Interventional

Despite the rapid adoption of the World Health Organization's 2013 guidelines, many children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health clinics (MCH). To achieve the UNAIDS goal eliminating mother-to-child HIV transmission, multiple, adaptive interventions will need to be implemented to improve adherence to the HIV continuum. The aim of this open label, parallel groups, randomized controlled trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district level to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo. Prior to randomization, the current monitoring and evaluation system will be strengthen to enable collection of high quality individual patient-level data necessary for the timely production of indicators and monitoring of program outcomes to inform CQI interventions. Following randomization, in health districts randomized to CQI, quality improvement (QI) teams will be established at the district level and at MCH clinics level. For 18 months, QI teams will be brought together quarterly to identified key bottlenecks in the care delivery system using data from the monitoring system, develop an action plan to address those bottlenecks, and implement the action plan at the level of their district or clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in DRC and other resource-limited settings to accelerate progress towards the goal of an AIDS free generation.

NCT ID: NCT03044899 Completed - Surgery Clinical Trials

African Surgical Outcomes Study (ASOS)

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.

NCT ID: NCT03025789 Recruiting - Clinical trials for Trypanosomiasis, African

Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

Start date: November 2016
Phase: Phase 3
Study type: Interventional

This study evaluates the effectiveness of fexinidazole administered to patients with g-HAT at all stages of the disease. The aim of the present study is to provide additional information on the effectiveness and safety of fexinidazole and to assess its use under conditions as close as possible to those in real life, both in patients treated on an out-patient basis and in the hospital setting, depending on clinical status

NCT ID: NCT02977715 Recruiting - Clinical trials for Monkeypox Virus Infection

IMVAMUNE® Smallpox Vaccine in Adult Healthcare Personnel at Risk for Monkeypox in the Democratic Republic of the Congo

Start date: February 23, 2017
Phase: Phase 3
Study type: Interventional

Monkeypox is a febrile rash illness caused by the monkeypox virus. Its natural occurrence in the DRC puts healthcare and frontline workers at high risk of acquiring monkeypox virus infections that can prevent them from performing work duties, compromise the overall healthcare delivery in an already fragile system, and can result in death (case fatality estimates are approximately 10%). This is an open-label prospective cohort study in up to 1,000 eligible healthcare workers at risk of monkeypox infection through their daily work. The study will document monkeypox exposure and infection in participants while concurrently evaluating the immunogenicity and safety of the vaccine, IMVAMUNE, in healthcare personnel in the DRC. Participation in the study is voluntary and open to male and female healthcare personnel ages 18 years and older in Tshuapa Province in The Democratic Republic of Congo who are at risk of monkeypox virus infection through their daily work or laboratory personnel performing diagnostic testing for monkeypox virus.

NCT ID: NCT02940756 Completed - Malaria Clinical Trials

Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo

TETRDC2016
Start date: March 15, 2017
Phase: Phase 4
Study type: Interventional

The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria in Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to play a major role in the malaria control in the region. The National Malaria Control program recommends artemisinin-based combination treatments (ACTs), in particular artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated malaria. Previous studies indicated that ACTs are still effective, with efficacy above the required threshold of 90%. It is required to assess regularly the efficacy of antimalarial drugs, in order to ascertain the relevance of treatment guidelines such that, in case of increasing failure rates, alternative options can be decided ontime. The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ Winthrop®), artemether-lumefantrine (Coartem Dispersible®) and dihydro-artemisinin-piperaquine (Eurartesim®) at day 42 in the treatment of uncomplicated Plasmodium falciparum malaria in six surveillance sites around DRC.

NCT ID: NCT02911441 Active, not recruiting - Maternal Depression Clinical Trials

Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments

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

This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of anxiety and depression living in insecure environments using a randomized controlled methodology. Key outcomes of interest include maternal mental health and infant cognitive development. The intervention will be delivered by community mental health workers who will be trained to administer 8 to 12 cognitive behavioral therapy sessions.

NCT ID: NCT02765139 Active, not recruiting - Domestic Violence Clinical Trials

Preventing Intimate-partner Violence: Impact Evaluation of Engaging Men Through Accountable Practice in Eastern DRC

Start date: February 2016
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the impact of Engaging Men in Accountable Practice (EMAP) on the prevention of violence against women and girls in North and South Kivu (DRC). The study is conducted jointly by the World Bank's Africa Gender Innovation Lab and the International Rescue Committee (IRC). EMAP is a program developed and implemented by the IRC to engage men to reflect on how to reduce and prevent intimate partner violence through 16 weekly group discussion sessions. The study is a cluster randomized control trial in which two groups of 25 self-selected men in 15 communities receive the EMAP intervention while in 15 other communities, 50 self-selected men receive an alternative intervention. Key outcomes examined include: (i) Experience of past year physical, sexual and psychological violence reported by women whose partners are EMAP participants; (ii) Participant's gender attitudes and behaviors, conflict and hostility management skills; (iii) Power sharing and communication within the couple.

NCT ID: NCT02689193 Recruiting - Fever Clinical Trials

IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres

IDIS
Start date: September 2014
Phase: N/A
Study type: Observational

The IDIS study aims to develop a new rapid diagnostic test for invasive salmonellosis using samples (blood, urine) collected from patients with fever and healthy controls at the Institute of Tropical Medicine (ITM) and collaborating centers. The samples are collected after informed consent and/or assent is given by the participant and are stored in a -80 ⁰C freezer after processing (centrifugation and/or aliquoting). Basic information regarding the patient and the samples are coded and stored in a protected Microsoft Access database. The samples will be shipped to Belgium for proteomic analysis. Identification of Salmonella specific proteins in the samples will hopefully support the development of a rapid diagnostic test. Once this test has been developed, the samples will also be used for validation and evaluation of this test.

NCT ID: NCT02656862 Completed - Clinical trials for Undifferentiated Acute Fever

Causes of Acute Undifferentiated Fever in Outpatients in the Democratic Republic of Congo

RESFANDI
Start date: October 2015
Phase: N/A
Study type: Observational [Patient Registry]

Fever is one of the main reasons for outpatient consultations in sub-saharan Africa. Following the introduction of malaria RDTs, clinicians face a high number of malaria-negative patients for whom they do not have a clear diagnosis. Through clinical history and examination, acute fever patients are categorized into: acute respiratory infections, urinary tract infections and other focal infections, diarrheal fevers and undifferentiated fevers. The latter being patients where no focal source of infections can be found during the consultation visit. In this proposal, the investigators focus on these acute undifferentiated fevers in an outpatient clinic. These fevers have the challenge of few point-of-care tests (POCT) available for the clinicians to identify the etiology of fever and guide treatment in resource-limited countries. As a consequence, over-prescription of antibiotics has increased. In order to improve patient outcomes while supporting judicious use of antimicrobials, there is an urgent need to change the management of febrile patients in low-income countries. This can only be achieved by providing evidence-based clinical guidelines for the management of these acute febrile patients. To develop such guidelines, epidemiological data on etiologies of undifferentiated fever need to be generated. The investigators will evaluate pathogen infection (such as dengue, chikungunya and others) in 640 patients ≥ 2 years old with acute undifferentiated fever. To evaluate the existence of aspecific and subclinical infections and co-infections, the investigators will also test a subsample of 200 patients with ARI, UTI, diarrheal fever and malaria. The investigators expect to have as main results: proportions of each syndrome among fever patients, key pathogens associated with undifferentiated fever and their clinical presentation and demographic characteristics.