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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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