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Treatment of Deficient Subclass or Anti-polysaccharide Antibody Response

NCT00522821 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2015-04-06

No results posted yet for this study

Summary

There is no consensus on the treatment of patients with recurrent infections and isolated immunoglobulin G (IgG)-subclass deficiency and/or selective antipolysaccharide antibody deficiency. Therefore, the Dutch Inter University Working Party will start a study in which the treatment with antibiotics is compared with intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder.

Conditions

Interventions

DRUG

intravenous immunoglobulins

* Adults: 600 mg/kg bodyweight every 3 weeks * Children: 800 mg/kg bodyweight every 3 week

DRUG

antibiotics

* Children ≥5-12: If well tolerated, 4 mg trimethoprim and 20 mg sulfamethoxazole per kg bodyweight once daily, every day of the week (max160/800mg/day), combined with 5 mg folic acid. * Adults and children ≥12 years or ≥40 kg: If well tolerated, 160 mg trimethoprim and 800 mg sulfamethoxazole once daily, every day of the week combined with 5 mg folic acid.

Sponsors & Collaborators

  • Prothya Biosolutions

    lead INDUSTRY

Principal Investigators

  • J T van Dissel, PhD, MD · LUMC

  • T W Kuijpers, PhD, MD · AIDS Malignancy Consortium

  • E AM Sanders, PhD, MD · UMCU

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00522821 on ClinicalTrials.gov