Malaria Clinical Trial
— JP015Official title:
Evaluation of Fosmidomycin and Clindamycin When Administered Concurrently to Adult Subjects With Acute Uncomplicated Plasmodium Falciparum Malaria
NCT number | NCT01002183 |
Other study ID # | JP015 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | October 26, 2009 |
Last updated | September 26, 2011 |
Verified date | August 2010 |
Source | Jomaa Pharma GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
The aim of this study is to evaluate the role of clindamycin and artesunate as possible combination partners for fosmidomycin to protect it from its susceptibility to recrudescent infections when used as monotherapy for acute Plasmodium falciparum malaria while retaining its excellent safety profile
Status | Withdrawn |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 55 Years |
Eligibility |
Inclusion Criteria: - male and female subjects aged 15 to 55 years - body mass index = 18.5kg/M2 - uncomplicated P falciparum malaria with acute manifestations - asexual parasitaemia between 500uL and 100,000uL - ability to tolerate oral therapy - able to give informed signed consent Exclusion Criteria: - signs of severe malaria, according to WHO criteria - body mass index = 18.5kg/M2 - pregnancy by history or by positive urine test - lactation - mixed plasmodial infection - concomitant disease masking assessment of response, including diabetes, - uncontrolled hypertension, heart failure, hepatic dysfunction (alanine-amino transferase >150 U/L), renal impairment (creatinine >125umol/L or 3mg/dl) - haemoglobin < 8g/dl - white cell count > 12000/uL - anti-malarial treatment within previous 28 days - symptomatic AIDS |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Jomaa Pharma GmbH | Mahidol University, Thammasat University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of fosmidomycin and clindamycin/artesunate when co-administered to adults with acute uncomplicated P.f. malaria. | 12 months | No | |
Secondary | To determine the viability and infectivity of gametocytes induced by the co-administration of fosmidomycin with clindamycin or with clindamycin plus artesunate to adult subjects with acute uncomplicated Plasmodium falciparum malaria. | 12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04601714 -
Baseline Cohort Malaria Morbidity Study
|
||
Withdrawn |
NCT04020653 -
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
|
Phase 2 | |
Terminated |
NCT04368910 -
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
|
Phase 3 | |
Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
Completed |
NCT02544048 -
Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
|
||
Completed |
NCT00527163 -
Role of Nitric Oxide in Malaria
|
||
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Active, not recruiting |
NCT04704674 -
Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
|
||
Completed |
NCT03276962 -
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
|
Phase 2 | |
Completed |
NCT04966871 -
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
|
Phase 1 | |
Completed |
NCT00289185 -
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
|
Phase 2 | |
Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
Active, not recruiting |
NCT06153862 -
Africa Ready Malaria Screening
|
N/A | |
Completed |
NCT04545905 -
Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
|
||
Recruiting |
NCT06278181 -
Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
|
||
Withdrawn |
NCT02793414 -
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
|
||
Completed |
NCT02793622 -
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
|
Phase 3 | |
Withdrawn |
NCT02793388 -
A Trial on Supervised Primaquine Use in Ethiopia
|
Phase 4 | |
Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
Completed |
NCT02536222 -
Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts
|
Phase 4 |