Treatment of Deficient Subclass or Anti-polysaccharide Antibody Response (Subklasse)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanquin
ClinicalTrials.gov Identifier:
NCT00522821
First received: August 29, 2007
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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: antibiotics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Treatment in Patients With Recurrent Infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response

Resource links provided by NLM:


Further study details as provided by Sanquin:

Primary Outcome Measures:
  • the number, duration and type of infection (including use of antibiotics to treat infections), days of fever, hospital admissions and, if applicable, days absent from school or work due to infections. [ Time Frame: 27 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements. [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2007
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Antibiotics

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
  • Adults: 600 mg/kg bodyweight every 3 weeks
  • Children: 800 mg/kg bodyweight every 3 week
Other Name: Nanogam
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.
Other Names:
  • co-trimoxazol
  • if not lorated: azitromycine
intravenous immunoglobulins

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
  • Adults: 600 mg/kg bodyweight every 3 weeks
  • Children: 800 mg/kg bodyweight every 3 week
Other Name: Nanogam
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.
Other Names:
  • co-trimoxazol
  • if not lorated: azitromycine

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IgG subclass deficiency and/or (selective) antipolysaccharide antibody deficiency
  • At least 2 physician documented infections before the start of the current treatment or in the last 6 months for newly diagnosed patients.
  • Total serum IgG > 4 g/l
  • ≥ 5 years of age
  • Informed consent

Exclusion Criteria:

  • Treatment with any other investigational drug within 7 days prior to study entry, or previous enrolment in this study
  • Allergic reactions against human plasma/plasma products, or co-trimoxazole
  • An ongoing progressive terminal disease
  • Pregnancy or lactation
  • History of (transient) cerebrovascular accident or coronary insufficiency
  • Renal insufficiency (plasma creatinin > 115 µmol/L; or creatinin clearance <20 ml/min)
  • An ongoing active disease causing general symptoms e.g. chronic active hepatitis or persistent enterovirus infection with ongoing systemic complaints
  • Detectable anti-IgA antibodies
  • Active systemic lupus erythematosus (SLE)
  • Glucose-6-phosphate hydrogenase deficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522821

Locations
Netherlands
VU
Amsterdam, Netherlands
AMC
Amsterdam, Netherlands
Jeroen Bosch Ziekenhuis
Den Bosch, Netherlands
UMCG
Groningen, Netherlands
LUMC
Leiden, Netherlands
AZM
Maastricht, Netherlands
UMC St Radboud
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
UMCU
Utrecht, Netherlands
Sponsors and Collaborators
Sanquin
Investigators
Principal Investigator: J T van Dissel, PhD, MD LUMC
Principal Investigator: T W Kuijpers, PhD, MD AIDS Malignancy Clinical Trials Consortium
Principal Investigator: E AM Sanders, PhD, MD UMCU
  More Information

No publications provided

Responsible Party: Sanquin
ClinicalTrials.gov Identifier: NCT00522821     History of Changes
Other Study ID Numbers: IUWP2005.01
Study First Received: August 29, 2007
Last Updated: January 10, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Sanquin:
IgG subclass deficiency
Anti-polysaccharide deficiency
therapy
Immunoglobulins, Intravenous
co-trimoxazole

Additional relevant MeSH terms:
IgG Deficiency
Dysgammaglobulinemia
Blood Protein Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 23, 2014