Trial · NCT02335905
Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children
NCT02335905, Phase 1, Phase 2, Completed, Baylor College of Medicine; results first posted 2021-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children. Trials, record NCT02335905. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02335905
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children
- NCT number
- NCT02335905
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Hematogenously Acquired Staphylococcus Aureus Osteomyelitis, Bone Infection, Osteomyelitis
- Interventions
- Ceftaroline Fosamil
- First posted
- 2015-01-12
- Last updated
- 2021-11-02
- Results first posted
- 2021-11-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to Adverse Events (AEs) | Predose and every 8 hours up to a maximum of 14 days for ceftaroline administration. | Evaluate the safety of Ceftaroline in pediatric subjects 1 to 17 years of age (inclusive) with acute hematogenous osteomyelitis at the end of intravenous therapy. |
| Secondary | Clinical Response at the Conclusion of IV Ceftaroline | 2 weeks | Clinical response (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) at the end of parenteral therapy (approximately days 5 to 14) by subject and by baseline pathogens although S.aureus is expected to be the predominant pathogen. |
| Secondary | Clinical Outcome at the Completion of Total Therapy (IV Ceftaroline Plus Oral Antibiotics) | 8 weeks | Clinical outcome (site of infection has complete resolution of pain, swelling and warmth, normal erythrocyte sedimentation rate and C-reactive protein level and the patient is able to use the affected extremity normally and is back to normal activities) at the completion of antibiotic treatment (IV ceftaroline plus oral antibiotics). |
| Secondary | Clinical Outcome During the One Year Follow-up Period After End of Antibiotic Treatment Which is Approximately 14 Months After Enrollment. | 14 months | Clinical outcome (no recurrence of pain, redness, swelling at site of original infection; absence of drainage from surgical wound; absence of pathological fracture; no other evidence of recurrence of infection at the original site of osteomyelitis and the patient is able to use the affected extremity normally and is back to normal activities) during the one year follow-up period which occurred approximately 14 month after enrollment and 12 months after completing antibiotic treatment. |
| Secondary | Proportion of Participants With Plasma Levels of Ceftaroline That Exceeds 1 μg/mL for Over 60% of a Dosing Interval | Blood for ceftaroline levels could be obtained once on study day 2 through day 5 post infusion of a dose of ceftaroline. | The mean and median concentrations of ceftaroline in plasma at the end of infusion will be determined. The proportion of patients with plasma levels of Ceftaroline that exceed 1 μg/mL for over 60% of a dosing interval will be determined. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to Adverse Events (AEs) | Predose and every 8 hours up to a maximum of 14 days for ceftaroline administration. | One patient never received ceftaroline after enrollment because his bone biopsy showed histiocytosis. | incidence | NUMBER |
| SECONDARY | Clinical Response at the Conclusion of IV Ceftaroline | 2 weeks | 10 patients who received ceftaroline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Outcome at the Completion of Total Therapy (IV Ceftaroline Plus Oral Antibiotics) | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Outcome During the One Year Follow-up Period After End of Antibiotic Treatment Which is Approximately 14 Months After Enrollment. | 14 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Participants With Plasma Levels of Ceftaroline That Exceeds 1 μg/mL for Over 60% of a Dosing Interval | Blood for ceftaroline levels could be obtained once on study day 2 through day 5 post infusion of a dose of ceftaroline. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to Adverse Events (AEs) | Ceftaroline Fosamil | 1 | incidence | ||
| Clinical Response at the Conclusion of IV Ceftaroline | Ceftaroline Fosamil | 7 | Participants | ||
| Clinical Outcome at the Completion of Total Therapy (IV Ceftaroline Plus Oral Antibiotics) | Ceftaroline Fosamil | 7 | Participants | ||
| Clinical Outcome During the One Year Follow-up Period After End of Antibiotic Treatment Which is Approximately 14 Months After Enrollment. | Ceftaroline Fosamil | 7 | Participants | ||
| Proportion of Participants With Plasma Levels of Ceftaroline That Exceeds 1 μg/mL for Over 60% of a Dosing Interval | Ceftaroline Fosamil | 10 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ceftaroline Fosamil | 11 | |
| Overall Study | COMPLETED | Ceftaroline Fosamil | 7 | |
| Overall Study | NOT COMPLETED | Ceftaroline Fosamil | 4 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | progression of infection | Infections and infestations | Ceftaroline Fosamil | 1 | 11 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ceftaroline Fosamil | 0 | 11 |
| Total, other adverse events | Ceftaroline Fosamil | 0 | 11 |
| Total, serious adverse events | Ceftaroline Fosamil | 1 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02335905
GET https://conductscience.org/api/trials/v1/NCT02335905/registered