Clinical trials: Paludism
Healthy
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants…
- Trial name
- NCT03261401
- Testing
- M5717
- Where
- Australia
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Malaria, Malaria Vaccines
Epidemiology Study of Malaria Transmission Intensity in Africa
The aim of this epidemiology study is to characterize in a standardized way malaria transmission intensity at the clinical trial centers participating in study 110021 (NCT00866619).
- Trial name
- NCT01190202
- Testing
- Blood sampling, Assessment of body temperature
- Where
- 8 sites in Burkina Faso, Gabon and 4 more
- Volunteers
- 21,618 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Candidate Vaccines RTS,S/AS02D (0.5 mL Dose) and RTS,S/AS02A (0.25 mL Dose) Administered IM According to a 0, 1, 2 Month Vaccination Schedule in Children Aged 3 to 5 Years Living in a Malaria-endemic Region of Mozambique.
GSK Biologicals is developing in partnership with the Malaria Vaccine Initiative at PATH a candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children living in malaria endemic areas.
- Trial name
- NCT00197067
- Testing
- RTS,S/AS02D and RTS,S/AS02A
- Where
- Mozambique
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety and Efficacy Study of Artesunate and Mefloquin in Children With Uncomplicated Malaria
The present study aims to investigate and to assess possible neurological and neuropsychiatric events in young children in west Africa with uncomplicated P.
- Trial name
- NCT00978172
- Testing
- artesunate and mefloquine
- Where
- Cameroon
- Volunteers
- 220 people
- Sponsor
- Mepha Ltd.
Malaria
A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 Months
The purpose of this study is to evaluate the safety and immunogenicity of reduced antigen doses and alternative vaccination regimes for RTS,S/AS01E in healthy children aged 5-60 months in a malaria-endemic area.
- Trial name
- NCT07036159
- Testing
- RTS,S/AS01E vaccine
- Where
- 2 sites in Rwanda
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model
The purpose of this study is to assess the safety, tolerability and immunogenicity of two dose levels (1x10^10 and 5x10^10 virus particles (vp)) of the adenovirus serotype (Ad) Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate…
- Trial name
- NCT01397227
- Testing
- Ad35.CS.01/Ad26.CS.01 low dose (1 x 10^10 vp), Ad 35.CS.01/Ad 26.CS.01 high dose (5 x 10^10 vp)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Plasmodium Falciparum Malaria
Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria
This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.
- Trial name
- NCT00709969
- Testing
- Artemether-lumefantrine
- Where
- 3 sites in Kenya, Nigeria and 1 more
- Volunteers
- 310 people
- Sponsor
- Novartis
Uncomplicated Plasmodium Falciparum Malaria
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2)
This was Cohort C2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
- Trial name
- PLATINUM (NCT07811908)
- Testing
- KAE609, SoC (Coartem), KLU156
- Where
- 13 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Malaria, Falciparum
A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.
- Trial name
- NCT06171113
- Testing
- GSK4024484C
- Where
- United Kingdom
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Falciparum Malaria
A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).
- Trial name
- NCT00894660
- Testing
- Amodiaquine (Test), Amodiaquine (Comparator)
- Where
- Singapore
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Pfizer
Tropical Infectious Diseases
Optimizing Sysmex Technology as an Innovative Tool to Differentiate Between Malaria (PALUdism) and BACterial Infections in a Malaria Endemic Region
Severe malaria and bacterial Blood Stream Infections (bBSI) are impossible to differentiate clinically. This poses a particular threat in low resource areas, where bBSI is often not diagnosed due to the unavailability of rapid…
- Trial name
- PALUBAC (NCT02669823)
- Testing
- None, treatment as actual best practice
- Where
- Burkina Faso
- Volunteers
- 930 people
- Sponsor
- Sysmex Europe GmbH
Malaria
Safety and Efficacy Dose of Artesunate Used in Combination With LAPDAP Treatment of Uncomplicated Falciparum Malaria
Drug resistance to a range of antimalarial treatments has become widespread in Africa, South East Asia and South America. Because the rapid spread of drug resistance threatens a public health disaster in these areas of the world…
- Trial name
- NCT00519467
- Testing
- Chlorproguanil-dapsone-artesunate (CDA)
- Where
- 2 sites in Malawi, The Gambia
- Volunteers
- 120 people
- Sponsor
- GlaxoSmithKline
Malaria,Falciparum
Pyramax in Asymptomatic Carriers of P. Falciparum Monoinfections
This study will assess the efficacy of Pyramax administered for three-day, two-day or one day, in clearing a P. falciparum infection in asymptomatic carriers. .
- Trial name
- NCT03814616
- Testing
- Pyronaridine tetraphosphate 180mg:artesunate 60mg
- Where
- 2 sites in The Gambia, Zambia
- Volunteers
- 300 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Malaria, Plasmodium Falciparum Malaria
Safety and Protective Efficacy of Intravenous Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chemoprophylaxis
TÜCHMI-002 is a single center, randomized, placebo-controlled, double-blinded, PfSPZ Challenge dose finding trial with two chemoprophylactic regimens and subsequent controlled human malaria infection (CHMI).
- Trial name
- NCT02115516
- Testing
- PfSPZ Challenge
- Where
- Germany
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)
The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection.
- Trial name
- NCT06294912
- Testing
- Plasmodium falciparum, MK-7602, Artemether/lumefantrine
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Malaria, Vivax
A Study to Evaluate the Pharmacokinetics of a Single Dose of Tafenoquine Co-administered With Either Artemether + Lumefantrine or Dihydroartemisinin + Piperaquine Tetraphosphate
This will be a single-centre, 5-cohort, randomized open-label, parallel-group study in healthy volunteer subjects. This study aims to provide sufficient pharmacokinetic (PK) evidence to support the safe usage of Tafenoquine (TQ)…
- Trial name
- NCT02184637
- Testing
- Tafenoquine, Dihydroartemisinin + Piperaquine tetraphosphate, Artemether + Lumefantrine
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Itraconazole
The study will assess the effect of multiple doses of itraconazole, a strong CYP3A4/5 inhibitor, on the PK of ganaplacide and lumefantrine in healthy participants.
- Trial name
- NCT05084651
- Testing
- Ganaplacide, Lumefantrine, Itraconazole
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Malaria
Safety, Tolerability and Efficacy of PfSPZ Vaccine in Healthy Children and Infants 5 Months - 9 Years Living in Kenya
This study will be conducted in Siaya County in Nyanza Province, western Kenya. Healthy children aged 5 months through 9 years of age living within approximately 10 km of the study clinic(s) (Siaya County Referral Hospital, or…
- Trial name
- NCT02687373
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Kenya
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Safety and Causal Prophylactic Efficacy of KAF156 in a Controlled Human Malaria Challenge Model
This study is designed to investigate the safety and causal prophylactic efficacy of KAF156 in healthy subjects using a controlled human malaria infection model.
- Trial name
- NCT04072302
- Testing
- KAF156
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Sepsis Newborn, Malaria
Immune Dysfunction in Newborn Sepsis
The aim of the project is to study neonatal immune dysfunction associated to the risk of newborn sepsis in a malaria endemic area in Benin.
- Conditions
- Sepsis Newborn, Malaria, Immune Responses
- Trial name
- RECIPAL (NCT03780712)
- Testing
- Non applicable
- Volunteers
- 585 people
- Sponsor
- BioMérieux