Prednisone Plus Chloroquine for the Treatment of Hyper-reactive Malarial Splenomegaly

• Status: Withdrawn
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lihir Medical Centre
• Treatments: Chloroquine; Chloroquine diphosphate; Immunoglobulin M; Prednisone

Criteria

Inclusion Criteria:

• Defining features of HMS including chronic massive splenomegaly (at least 10 cm below the costal margin); serum Immunoglobulin M elevated more than 3.1 g/L and high malarial antibody titres (above 640).

• Evidence of the polyclonal nature of the lymphocytes by serum immunoglobulin free light chains.

• Aged at least 18 years

• Haemoglobin level of > 5 mg/d

Exclusion Criteria:

• known allergy to chloroquine,

• use of anti-malarial treatment within the preceding month,

• suspected coexisting diseases in which glucocorticoids are contraindicated (e.g. diabetes mellitus, peptic ulcer disease or any acute infection as defined clinically), and

• splenomegaly secondary to known infectious or haematological causes