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NCT ID: NCT01722539 Completed - Healthy Clinical Trials

Impact IPT With Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine in Schoolchildren

PIP-IPT
Start date: November 2012
Phase: Phase 3
Study type: Interventional

Considering the facts that: (i) IPT of malaria provides substantial protection against anaemia and malaria in school children (ii); SP resistance has no significant impact on the prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators hypothesize that antimalarial IPT with SP and SP-PQ will improve haemoglobin concentration, reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and school performance in school-aged children of Congo.

NCT ID: NCT01685827 Completed - Sleeping Sickness Clinical Trials

Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2

Start date: October 2012
Phase: Phase 2/Phase 3
Study type: Interventional

This clinical trial is designed to prove the efficacy and safety of Fexinidazole as an oral treatment for human african trypanosomiasis in advanced stage. The Fexinidazole is compared to reference treatment NECT. The trial will try to demonstrate that Fexinidazole is not inferior to NECT treatment.

NCT ID: NCT01625117 Completed - Clinical trials for Posttraumatic Stress Disorder

Mental Health and Aggression in Congolese Ex-combatants

Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is examine, whether a treatment approach, which is specifically tailored for perpetrators who have participated in violence (a variant of Narrative Exposure Therapy) is effective in the reduction of instrumental aggression and symptoms of posttraumatic stress disorder.

NCT ID: NCT01619878 Completed - Clinical trials for Acute Uncomplicated Falciparum Malaria

Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg

Start date: October 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.

NCT ID: NCT01542398 Completed - Clinical trials for Psychological Distress

A Family-based, Resilience-focused Intervention for War-affected Communities in North-eastern Democratic Republic of Congo

Start date: March 2012
Phase: Phase 1
Study type: Interventional

The main research question of the study is whether a family-based, life-skills focused psychosocial intervention is effective in reducing psychological distress and stigma and improving inter-personal relations and functioning among war-affected children in the Democratic Republic of Congo.

NCT ID: NCT01509872 Completed - Depression Clinical Trials

Psychological and Psychosocial Intervention With War-Affected Children

Start date: October 2011
Phase: N/A
Study type: Interventional

The investigators are interested in knowing whether a group-based, trauma-focused intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general, non trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing post-traumatic stress, depression and anxiety and conduct problems and increasing pro-social behavior among war-affected children in the Democratic Republic of Congo.

NCT ID: NCT01483261 Completed - Clinical trials for Post-traumatic Stress Symptoms

An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC

Start date: May 2011
Phase: Phase 2
Study type: Interventional

To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.

NCT ID: NCT01428232 Completed - Breastfeeding Clinical Trials

Effectiveness of Well-child Clinics as the "Community" Basis of Step 10 of the Baby Friendly Hospital Initiative

Start date: May 2012
Phase: N/A
Study type: Interventional

A cluster-randomized controlled trial will be conducted in the Democratic Republic of Congo to compare rates of early initiation and exclusive breastfeeding between mothers who give birth in hospitals with the current standard of care, mothers who give birth in hospitals that have implemented the first nine steps of the Baby-Friendly Hospital Initiative, and mothers who give birth in hospitals that have implemented all ten steps of the Baby-Friendly Hospital Initiative, with the 10th step being the provision of breastfeeding support during well-child clinic visits.

NCT ID: NCT01374581 Completed - Malaria Clinical Trials

Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria

QuinAct
Start date: May 2012
Phase: Phase 3
Study type: Interventional

This is a bi-centric phase IIIb, randomized, open label, 3-arm clinical trial performed to investigate the impact of retreatment with an Artemisinin-Based Combination (ACT), for example Arthemeter-Lumefantrine (AL) in Uganda (Ug) and artesunate-amodiaquine (ASAQ) in RDCongo, on malaria incidence and its potential selection of resistant strains. Patients will be followed-up for efficacy and safety during 42 days after treatment with the first line therapy recommended by the national authorities(arthemeter-lumefantrine in Uganda and artesunate-amodiaquine in RDCongo) and retreated the patients either with the same ACT or an other ACT or oral Quinine + clyndamicin. The investigators hypothesize that (re)treatment with the first line ACT treatment beyond 14 days is as efficacious as any other rescue treatment, without the risk of selecting drug resistant strains.

NCT ID: NCT01282788 Completed - Malnutrition Clinical Trials

Efficacy of Caterpillar Cereal for Complementary Feeding in the Democratic Republic of Congo

CAT02
Start date: January 2011
Phase: N/A
Study type: Interventional

Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer from stunting of linear growth by 12 months of age. Stunting presumably results from breast milk supplementation after 6 months of age with complementary foods (CF) that provide inadequate protein and micro-nutrients. Although supplementation with selected micro-nutrients may avoid certain deficiency states, CF with animal source foods may be necessary to avoid stunting. Meat is not readily available in many Central African countries. However caterpillars, which are locally available and abundant, are a common staple in adult diets and may be a suitable substitute for animal source proteins in CF. The investigators developed a cereal made from dried caterpillars that has a nutrient content that appears to be ideal for CF and demonstrated maternal and infant acceptability. This study will investigate the efficacy in prevention of stunting of growth resulting from inadequate complementary foods. A sub-study will evaluate the biologic effects of the caterpillar cereal to determine whether caterpillar cereal prevents iron deficiency anemia, reduces the incidence of neurodevelopmental impairment or infectious diseases.