Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-25 @ 9:02 PM
Study NCT ID:
NCT02335905
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2014-12-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Phase 1/2 Trial of Ceftaroline for the Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is looking at an antibiotic medicine, Ceftaroline Fosamil (Ceftaroline), which fights infections like the one the subject has. Ceftaroline is effective against S.aureus germs including those that are called Methicillin Resistant Staphylococcus aureus (MRSA.)
Ceftaroline has been approved by the U.S. Food and Drug Administration (FDA) for use in adults and children with Community-Acquired Bacterial Pneumonia \[a type of lung infection\] and Acute Bacterial Skin and Skin Structure Infections. Ceftaroline is not yet approved for treatment in subjects with hematogenous osteomyelitis, therefore, the use of Ceftaroline in this research study is considered "investigational".
The goal of this research study is to find out what side effects there may be when children are taking Ceftaroline and to study how effective Ceftaroline is in treating bone infections due to Staphylococcus aureus in children. The investigators are also studying what the body does to the study drug, Ceftaroline, and if the doses the investigators use result in blood levels that the investigators think are going to be effective against bone infections in children. This is called pharmacokinetics (PK).
Ceftaroline has been approved by the U.S. Food and Drug Administration (FDA) for use in adults and children with Community-Acquired Bacterial Pneumonia \[a type of lung infection\] and Acute Bacterial Skin and Skin Structure Infections. Ceftaroline is not yet approved for treatment in subjects with hematogenous osteomyelitis, therefore, the use of Ceftaroline in this research study is considered "investigational".
The goal of this research study is to find out what side effects there may be when children are taking Ceftaroline and to study how effective Ceftaroline is in treating bone infections due to Staphylococcus aureus in children. The investigators are also studying what the body does to the study drug, Ceftaroline, and if the doses the investigators use result in blood levels that the investigators think are going to be effective against bone infections in children. This is called pharmacokinetics (PK).
Detailed Description:
This is a Phase 1/2, open-label, single-center study to determine safety and tolerability of Ceftaroline in pediatric subjects 1 to 17 years of age (inclusive) with signs and symptoms of acute hematogenous osteomyelitis at the end of intravenous therapy. After informed consent/assent is obtained, Ceftaroline will be administered intravenously. After the subject has been afebrile for at least 48 hours, has negative blood cultures, is clearly improving in general, is able to eat and drink, and is able to use or move the involved extremity, the subject may be switched to oral antibiotic administration.
The duration of subject participation from signing the informed consent form will be up to 14 months \[(includes screening period (1 Day), study IV drug administration (approximately 2-14 Days), Standard of Care Oral Drug Administration (4-5 weeks) (the total maximum treatment period is typically 6 weeks), and a follow-up visit 12 months after the last dose of study drug)\]. Baseline assessments for study eligibility will occur within 24 hours before the first dose of study drug. A minimum of 2 days (48 hours) of study drug administration is required.
Some of the tests and procedures completed during this study may be part of regular care for the subject's condition. Some tests and procedures will be done only for study purposes. Some regular procedures may also be completed more often as part of the research study.
Study assessments:
1. Past and Current Medical History: A detailed review of the subject's medical history, including demographics, concomitant medication review, medical/surgical history will be performed.
2. Vital Signs: Weight, height, blood pressure, pulse rate, and body temperature, will be recorded.
3. Physical Exam: Physical exam will include, evaluation of subject's overall health, examination site of infection, and assessment of subject's ability to move affected limb.
4. Safety Laboratory Assessments: Routine laboratory monitoring including liver function tests will be done 24 hours prior to enrollment and weekly during Ceftaroline treatment, and the completion of Ceftaroline treatment and at the follow-up visit. Isolate susceptibility testing will be done at baseline visit.
5. Pregnancy testing: For females of child-bearing potential, urine pregnancy will be performed prior to and after completing antibiotic treatment.
6. Pharmacokinetics Assessment: One PK blood sample will be obtained from all subjects who receive Ceftaroline fosamil.
The duration of subject participation from signing the informed consent form will be up to 14 months \[(includes screening period (1 Day), study IV drug administration (approximately 2-14 Days), Standard of Care Oral Drug Administration (4-5 weeks) (the total maximum treatment period is typically 6 weeks), and a follow-up visit 12 months after the last dose of study drug)\]. Baseline assessments for study eligibility will occur within 24 hours before the first dose of study drug. A minimum of 2 days (48 hours) of study drug administration is required.
Some of the tests and procedures completed during this study may be part of regular care for the subject's condition. Some tests and procedures will be done only for study purposes. Some regular procedures may also be completed more often as part of the research study.
Study assessments:
1. Past and Current Medical History: A detailed review of the subject's medical history, including demographics, concomitant medication review, medical/surgical history will be performed.
2. Vital Signs: Weight, height, blood pressure, pulse rate, and body temperature, will be recorded.
3. Physical Exam: Physical exam will include, evaluation of subject's overall health, examination site of infection, and assessment of subject's ability to move affected limb.
4. Safety Laboratory Assessments: Routine laboratory monitoring including liver function tests will be done 24 hours prior to enrollment and weekly during Ceftaroline treatment, and the completion of Ceftaroline treatment and at the follow-up visit. Isolate susceptibility testing will be done at baseline visit.
5. Pregnancy testing: For females of child-bearing potential, urine pregnancy will be performed prior to and after completing antibiotic treatment.
6. Pharmacokinetics Assessment: One PK blood sample will be obtained from all subjects who receive Ceftaroline fosamil.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TEF-IT-43/IIT-2017-10048 | OTHER_GRANT | Allergan | View |