Patients with suspected or documented osteomyelitis in the peripheral skeleton including patients with loosening of joint prosthesis or diabetic foot. At least one of following signs or symptoms is required: localized pain, nonhealing skin ulceration, fever > 37.8°C for at least 3 days, leukocyte count in excess of upper normal limits, erythrocyte sedimentation rate in excess of upper normal limits, radiographic findings suggestive of osteomyelitis, or positive blood or wound cultures.
Conditions
Interventions
Product Name: Scintimun® Granulocyte
Product Code: MAb-BW 250/183
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Besilesomab
CAS Number: 537694-98-7
Concentration unit: mg
Sponsors
CIS bio International
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients screened positively for the study must fulfill all the following criteria: 1. Male or female (if female of child-bearing potential, negative pregnancy test required before any radiotracer administration), 2. Age ³ 18 years, 3. Patients with suspected or documented osteomyelitis (acute, subacute, chronic) in the peripheral skeleton including patients with loosening of joint prosthesis and patients with diabetic foot. In addition, at least one of the following signs or symptoms is required: localized pain, nonhealing skin ulceration, fever > 37.8°C for at least 3 days, leukocyte count in excess of the upper normal limits, erythrocyte sedimentation rate in excess of the upper normal limits, radiographic findings suggestive of osteomyelitis, or positive blood or wound cultures, 4. Patients who have signed a written informed consent form to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients displaying any of the following criteria will not be included: 1. Pregnant women and women with a positive pregnancy test prior to the first study drug administration, 2. Breastfeeding women and women of child bearing potential not using a reliable means of contraception, 3. Patients with a known allergy to mouse proteins or a positive mouse proteins-specific Ig E test (allergy test) prior to the first study drug administration, 4. Patients with a positive HAMA test prior to the first study drug administration 5. Patients with rare hereditary problems of fructose intolerance, 6. Severe disease or surgery (except for orthopedic reasons) within the last 4 weeks prior to the first study drug administration, 7. A history of hypersensitivity to one or several medications (abnormal or idiosyncratic reactions to a drug), 8. Patients with leukocyte count < 6.109/L (6,000/mm3), 9. The use of non-steroid anti-inflammatory drugs and corticosteroids within 3 days prior to the first injection and up to 24 hours after the last injection, 10. Receipt of cancer chemotherapy and immunosuppressive drugs or immunomodulators within 4 weeks prior to study entry, 11. Patient showing laboratory parameters which in the opinion of the investigator preclude participation for reasons of the patient’s safety. 12. Nuclear medicine diagnostic procedure within 2 days prior to the first injection, 13. Participation in another clinical study within one month prior to screening, 14. Uncooperative, in the investigator's opinion, 15. Linguistic or psychological inability to sign the informed consent form and/or take part in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the present study is to assess the agreement rate of Scintimun® Granulocyte and 99mTc-WBCs with regard to the diagnosis of nfection/inflammation by immunoscintigraphy, based on the evaluations of three blinded and independent readers in the absence of a standard of reference (SOR) to evaluate the true status.;Secondary Objective: The secondary objectives are to assess the image quality, and evaluate the safety of the two products, in particular, the possible HAMA (Human Anti-Mouse Antibodies) factor induction after the investigational product administration. Additional objective will be determination of agreement rates between Scintimun® Granulocyte and 99mTc-WBCs per reader and based on the evaluation of clinical investigators.;Primary end point(s): The primary analysis is the evaluation of the agreement rate of Scintimun® Granulocyte and labeled WBCs with regard to the diagnosis of infection/inflammation by immunoscintigraphy, based on the evaluations of three blinded and independent readers in a blinded read. The primary efficacy variable will be calculated as an average across the reader results ("average reader") as primary analysis and separately for each reader as secondary analysis. The endpoint "agreement rate" was chosen in absence of an adequate standard of reference, so that diagnostic parameters like sensitivity and specificity could not be calculated. | — |
Countries
Czech Republic, Germany, Hungary, Netherlands
Outcome results
None listed