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Sponsored by: |
Sanquin |
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Information provided by: | Sanquin |
ClinicalTrials.gov Identifier: | NCT00522821 |
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.
Condition | Intervention | Phase |
---|---|---|
IgG Deficiency Infections |
Drug: intravenous immunoglobulins Drug: co-trimoxazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Treatment in Patients With Recurrent Infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response |
Estimated Enrollment: | 40 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A
A: co-trimoxazole prophylactically for 12 months followed by intravenous immunoglobulin treatment for 12 months. Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given. |
Drug: intravenous immunoglobulins
|
B
B: intravenous immunoglobulin treatment for 12 months followed by co-trimoxazole prophylactically for 12 months. Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given. |
Drug: intravenous immunoglobulins
|
There is no consensus on the treatment of patients with recurrent infections and isolated IgG-subclass deficiency and/or selective antipolysaccharide antibody deficiency. At present, there are no robust criteria to predict which patient will or will not respond adequately to antibiotic treatment or to IVIG. Furthermore, it is unknown whether IVIG treatment improves the quality of life in these patients. Therefore, the Dutch InterUniversity Working Party intends to start a study in this patient group. In this study, treatment for a year with antibiotics will be compared with a year intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder.
The patient will visit the clinic every 3 months during which laboratory tests and physiological measurements will be performed. Moreover the occurrence of infections and fever, the use of antibiotics, hospital admissions, and quality of life will be documented.
The study should result in a national harmonization in the treatment of this patient group. To this end, the results of the study will be used to compile a treatment protocol for this group of patients in the Netherlands and if applicable also in other countries worldwide.
Ages Eligible for Study: | 5 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: P S Strengers, MD | p.strengers@sanquin.nl | |
Contact: I Kleine Budde, PhD | i.kleinebudde@sanquin.nl |
Netherlands | |
AZM | Recruiting |
Maastricht, Netherlands | |
Contact: J W Cohen Tervaert, PhD, MD | |
Principal Investigator: J W Cohen Tervaert, PhD, MD | |
Erasmus MC | Not yet recruiting |
Rotterdam, Netherlands | |
Contact: P M van Hagen, PhD, MD | |
Contact: N G Hartwig, PhD, MD | |
Principal Investigator: P M van Hagen, PhD, MD | |
Principal Investigator: N G Hartwig, PhD, MD | |
AMC | Recruiting |
Amsterdam, Netherlands | |
Contact: R JM ten Berge, PhD, MD | |
Contact: T W Kuijpers, PhD, MD | |
Principal Investigator: R JM ten Berge, PhD, MD | |
Principal Investigator: T W Kuijpers, PhD, MD | |
LUMC | Recruiting |
Leiden, Netherlands | |
Contact: J T van Dissel, PhD, MD | |
Contact: M J Van Tol, PhD, MD | |
Principal Investigator: J T van Dissel, PhD,MD | |
Principal Investigator: M J van Tol, PhD,MD | |
Principal Investigator: R G Bredius, PhD,MD | |
Jeroen Bosch Ziekenhuis | Not yet recruiting |
Den Bosch, Netherlands | |
Contact: E de Vries, PhD,MD | |
Principal Investigator: E de Vries, PhD,MD | |
UMC St Radboud | Not yet recruiting |
Nijmegen, Netherlands | |
Contact: M van Deuren, PhD,MD | |
Contact: C RM Weemaes, PhD,MD | |
Principal Investigator: M van Deuren, PhD,MD | |
Principal Investigator: C RM Weemaes, PhD,MD | |
UMCU | Recruiting |
Utrecht, Netherlands | |
Contact: E AM Sanders, PhD,MD | |
Contact: I M Hoepelman, PhD,MD | |
Principal Investigator: E AM Sanders, PhD,MD | |
Principal Investigator: I M Hoepelman, PhD,MD | |
Principal Investigator: G Rijkers, PhD | |
VU | Not yet recruiting |
Amsterdam, Netherlands | |
Contact: M A van Agtmael, PhD,MD | |
Principal Investigator: M van Agtmael | |
UMCG | Recruiting |
Groningen, Netherlands | |
Contact: C GM Kallenberg, PhD,MD | |
Principal Investigator: C GM Kallenberg, PhD,MD |
Principal Investigator: | J T van Dissel, PhD, MD | LUMC |
Principal Investigator: | T W Kuijpers, PhD, MD | AMC |
Principal Investigator: | E AM Sanders, PhD, MD | UMCU |
Responsible Party: | LUMC ( J.T. van Dissel ) |
Study ID Numbers: | IUWP2005.01 |
Study First Received: | August 29, 2007 |
Last Updated: | February 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00522821 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
IgG subclass deficiency Anti-polysaccharide deficiency therapy Immunoglobulins, Intravenous co-trimoxazole |
Trimethoprim Sulfamethoxazole Blood Protein Disorders Hematologic Diseases Trimethoprim-Sulfamethoxazole Combination Recurrence Immunologic Deficiency Syndromes |
Folic Acid Antibodies Immunoglobulins, Intravenous IgG Deficiency Rho(D) Immune Globulin Immunoglobulins |
Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Immune System Diseases Immunologic Factors Physiological Effects of Drugs Anti-Infective Agents, Urinary |
Infection Renal Agents Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Dysgammaglobulinemia |