Clinical trials: Malaria Falciparum
Malaria
Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients
The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate…
- Trial name
- NCT00541385
- Testing
- pyronaridine artesunate, arthemeter lumefantrine
- Where
- 8 sites in Burkina Faso, Côte d’Ivoire and 6 more
- Volunteers
- 535 people
- Sponsor
- Medicines for Malaria Venture
Malaria
Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP
A single-centre Phase 1b study to assess the safety, tolerability, pharmacokinetic profile, and antimalarial activity of single doses of coadministered artefenomel (OZ439) and piperaquine phosphate (PQP) against early Plasmodium…
- Trial name
- NCT03542149
- Testing
- 480 mg Piperaquine phosphate, 640 mg Piperaquine phosphate, 200 mg OZ 439
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Plasmodium Falciparum Malaria
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.
- Trial name
- NCT00312663
- Testing
- Falciparum Malaria Protein 11 with AS01B adjuvant.
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria
A Study to Characterise the Antimalarial and Transmission Blocking Activity of a Single Dose of DSM265 or OZ439 in Healthy Subjects With Induced Blood Stage Plasmodium Falciparum or Plasmodium Vivax Infection
Part A -Cohort 1 DSM265 will be administered as a single dose (400 mg). For cohort 1 only, an additional single dose (400 mg) of DSM265 may be given if gametocytemia develops.
- Trial name
- DSMOZ-2 (NCT02573857)
- Testing
- DSM265, OZ439
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Malaria
Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400 mg/day (Part 1) and single dosing with KAF156 at…
- Trial name
- NCT01753323
- Testing
- KAF156
- Where
- 5 sites in Thailand, Vietnam
- Volunteers
- 43 people
- Sponsor
- Novartis Pharmaceuticals
Plasmodium Falciparum Malaria
Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali
Malaria is a disease that affects many people in Africa. Malaria is caused by germs spread by mosquito bites. The purpose of this study is to compare the number of children who get malaria after receiving an experimental malaria…
- Trial name
- NCT00460525
- Testing
- FMP2.1/AS02A, Rabies Vaccine
- Where
- Mali
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria, Plasmodium Falciparum Malaria
FMP2.1/AS02A: Rabies Vaccine Malaria-Experienced Adults in Bandiagara, Mali
Malaria is a disease that affects many people in Africa and in Mali. It is caused by germs that are spread by mosquito bites. This study will look at the safety, effectiveness, and best dose of an experimental malaria vaccine in…
- Trial name
- NCT00349713
- Testing
- FMP2.1/AS02A, Rabies vaccine (RabAvert)
- Where
- Mali
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria, Falciparum
Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function
To evaluate the potential effects of artemether- lumefantrine on the auditory function
- Trial name
- NCT00444106
- Testing
- Artesunate-mefloquine, Atovaquone-proguanil, Artemether-lumefantrine
- Where
- Colombia
- Volunteers
- 265 people
- Sponsor
- Novartis
Plasmodium Falciparum Malaria
Superiority of ArTiMist Versus Quinine in Children With Severe Malaria
The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by >= 90% within 24 hours after the start of treatment in children with severe…
- Trial name
- NCT01258049
- Testing
- Artemether Sublingual Spray, Quinine
- Where
- 3 sites in Burkina Faso, Ghana and 1 more
- Volunteers
- 151 people
- Sponsor
- Proto Pharma Ltd
Malaria
Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children
The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.
- Trial name
- NCT01323972
- Testing
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
- Where
- 2 sites in Nigeria
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali
This study tested the safety of a new malaria vaccine in adults in Mali, West Africa, and measured the ability of the vaccine to stimulate antibodies directed against the malaria protein that the vaccine is based on.
- Trial name
- NCT00308061
- Testing
- FMP1/AS02A, Imovax Rabies Vaccine
- Where
- Mali
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Malaria
Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...
Background: Malaria remains a major global health problem. Malaria is spread by the bite of mosquitos. Africa is the region of the world where most people get malaria. Sanaria PfSPZ Challenge is a malaria vaccine.
- Trial name
- NCT03952650
- Testing
- Chloroquine Phosphate, PfSPZ Challenge, Pyrimethamine
- Where
- Mali
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Malaria, Malaria Vaccines
Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated…
- Trial name
- NCT01345240
- Testing
- GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Engerix-B™ vaccine, Infanrix/Hib™ vaccine
- Where
- 2 sites in Burkina Faso, Ghana
- Volunteers
- 705 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination.
- Trial name
- NCT03276962
- Testing
- RTS,S/AS01E (Full dose), RTS,S/AS01E (1/5th dose), Rabies vaccine
- Where
- 2 sites in Ghana, Kenya
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
This epidemiology study was conducted in parallel with the EPI-MAL-002 (NCT02374450) and EPI-MAL-003 (NCT03855995) studies, enrolling participants from the same health and demographic surveillance system (HDSS) (or equivalent…
- Trial name
- NCT02251704
- Testing
- Assessment of body temperature, Blood sampling
- Where
- 12 sites in Burkina Faso, Ghana and 4 more
- Volunteers
- 54,115 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria
This study aimed to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for…
- Trial name
- KALUMA (NCT05842954)
- Testing
- KLU156, Coartem
- Where
- 32 sites in Burkina Faso, Côte d’Ivoire and 10 more
- Volunteers
- 1,720 people
- Sponsor
- Novartis Pharmaceuticals
Malaria, Malaria,Falciparum
A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI
USSPZV7 is a randomized, phase 1, double-blind, placebo-controlled trial of Sanaria® PfSPZ Vaccine administered on Days 1, 8 and 29 by direct venous inoculation (DVI) to assess safety, tolerability, immunogenicity, and vaccine…
- Trial name
- NCT05604521
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (7G8), Normal Saline
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Phase 1/2a Trial of Pf GAP p52-/p36- Sporozoite Malaria Vaccine
The purpose of this study is to assess safety and tolerability of escalating doses of a genetically attenuated parasite malaria vaccine (p52-/p36- GAP vaccine) in healthy malaria-naive adults.
- Trial name
- NCT01024686
- Testing
- p52-/p36- GAP Vaccine, p52-p36- GAP Vaccine
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Seattle Children's Hospital
Malaria
Safety, Tolerability and Chemoprotective Activity of P218 in PfSPZ Challenge Model
This was a single centre, randomised, double-blind, placebo-controlled Phase Ib study, to evaluate the safety, tolerability and chemoprotective activity of P218 in a controlled P. falciparum sporozoite infection model.
- Trial name
- NCT03707041
- Testing
- P218 (1000 mg) Oral Capsules, P218 (100 mg) Oral Capsules, PfSPZ Challenge
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Falciparum Malaria
Efficacy of ArTiMist™ in Children
The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with…
- Trial name
- NCT01047436
- Testing
- Quinine, Artemether
- Volunteers
- 31 people
- Sponsor
- Proto Pharma Ltd