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

NCT01785979 | Withdrawn Phase 3

• 1 other identifier: LiHMS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyper-reactive Malarial Splenomegaly; Malaria; Anaemia

Outcome Measures

Primary Outcomes (1)

• composite clinical & immunological endpoint

  Clinical cure, defined as a sustained reduction in spleen size of at least 40% at the 12 month follow up examination, compared with the spleen size at the baseline examination. Immunological cure, defined as a two-fold decrease of total immunoglobulin M levels is also needed.

  12 months

Secondary Outcomes (5)

• 3 months intermediate clinical cure

  3 months

• 6 months intermediate clinical cure

  6 months

• Anaemia

  12 months

• Malaria episode

  12 months

• Bacterial infection

  12 months

Study Arms (2)

Prednisone induction - chloroquine

EXPERIMENTAL

0.5 mg/Kg daily of prednisone for 4 weeks after randomization, 0.25 mg daily for weeks 5-6, 0.15 mg daily for week 7 and 2.5 mg daily for week 8 and chloroquine at a fixed dose (300 mg base per week) for months 1-12

Drug: prednisone induction - chloroquine

chloroquine

ACTIVE COMPARATOR

chloroquine at a fixed dose (300 mg base per week) for months 1-12

Drug: Chloroquine

Interventions

prednisone induction - chloroquine DRUG

At study entry, the patients will undergo physical examination and laboratory tests, including blood cell count, malaria microscopy, immune-chromatographic test for malaria antigen, malaria serology titers, and serum protein studies with immunoglobulin M quantification, immune-fixation and immunoglobulin free light chains measurement. We will assess all participants at 1, 3, 6 and 12 months after enrollment. Clinical examination and routine laboratory tests are done every 3 months during the follow-up period. Immunoglobulin M quantification and malaria serology are done at baseline, and at month 12 visit.

Also known as: Deltasone,, Orasone,, Prednicen-M

Prednisone induction - chloroquine

Chloroquine DRUG

At study entry, the patients will undergo physical examination and laboratory tests, including blood cell count, malaria microscopy, immune-chromatographic test for malaria antigen, malaria serology titers, and serum protein studies with immunoglobulin M quantification, immune-fixation and immunoglobulin free light chains measurement. We will assess all participants at 1, 3, 6 and 12 months after enrollment. Clinical examination and routine laboratory tests are done every 3 months during the follow-up period. Immunoglobulin M quantification and malaria serology are done at baseline, and at month 12 visit.

Also known as: Aralen, Resochin, Alchroquin

chloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lihir Medical Centre: lead

Study Sites (1)

Lihir medical Centre

Londolovit, New Ireland Province, Papua New Guinea

Location

MeSH Terms

Conditions

Malaria; Anemia

Interventions

Prednisone; Chloroquine; chloroquine diphosphate

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Oriol Mitja, PhD

  Lihir Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Medical Officer

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 7, 2013
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

PA (1)