Malaria Clinical Trial
Official title:
Prednisone Plus Chloroquine Versus Chloroquine for the Treatment of Hyper-reactive Malarial Splenomegaly in Papua New Guinea: a Randomized Open-label Trial
This randomized clinical trial will address a complication related to recurrent episodes of malaria in endemic areas - hyper-reactive malarial splenomegaly. We aim to assess the efficacy of chloroquine after prednisone-induction therapy compared to standard treatment of chloroquine alone in the treatment of adult patients with newly diagnosed hyper-reactive malarial splenomegaly.
Hyper-reactive malarious splenomegaly (HMS) is a known chronic autoimmune complication in
areas where malaria is endemic. Patients with HMS complain most commonly of abdominal
swelling or pain from the enlarged spleen and the condition is defined using clear clinical
and laboratory criteria. HMS appears benign in most patients when seen first but if
untreated, it leads to severe anaemia and also acute bacterial infections. There is familiar
and ethnic clustering suggesting genetic basis. High prevalence rates have been reported in
certain areas of Papua New Guinea, and Venezuela, and HMS is also common in parts of
sub-Saharan Africa, including Sudan and Ghana.
The treatment of HMS is still empirical since no randomized trials have been done so far.
Long term anti-malarial chemoprophylaxis is deemed the mainstay of therapy, but the optimal
drug-regimen and duration are unknown. Three to six months may pass before a response is
observed, and relapses may occur when therapy is discontinued.
On the basis of the observed benefit in experimental studies, glucocorticoids have been used
for severe hyper-reactive malarial splenomegaly in various case reports. Because these cases
had a favourable outcome and the drug tolerability was good, prednisone has become an
attractive therapeutic option for this disease. Central to the pathophysiology of HMS is the
overproduction of Immunoglobulin M due to a functional CD8 T-cell defect and the consequent
expansion and activation of B lymphocytes. Glucocorticoids may have an immediate effect due
to inhibition of the sequestration of immunoglobulin coated red blood cells by the
mononuclear phagocyte system and a later effect due to glucocorticoid-induced inhibition of
antibody synthesis. We aim to assess the efficacy of chloroquine after prednisone-induction
therapy compared to chloroquine alone in the treatment of adult patients with newly
diagnosed hyper-reactive malarial splenomegaly.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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
|
||
| Withdrawn |
NCT02793388 -
A Trial on Supervised Primaquine Use in Ethiopia
|
Phase 4 | |
| Completed |
NCT02793622 -
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
|
Phase 3 | |
| Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
| Completed |
NCT02315690 -
Evaluation of Reactive Focal Mass Drug Administration for Malaria Elimination in Swaziland
|
Phase 3 |