OsteomyelitisPIVVOTNCT02311452
Comparative Effectiveness of Intravenous v. Oral Antibiotic Therapy for Serious Bacterial Infections
An observational study of Osteomyelitis and Pneumonia, run by Children's Hospital of Philadelphia.
Trial summary
Some children get serious bacterial infections that require hospitalization and then a long course of antibiotics to completely treat the infection. Examples of these serious infections include ruptured appendicitis (when the appendix gets inflamed and bursts, releasing bacteria into the abdomen), complicated… Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Osteomyelitis, Pneumonia, Appendicitis
- What is being tested?
- Peripherally Inserted Central Catheter (PICC)
- Type of treatment
- Medical device
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children hospitalized for acute osteomyelitis, complicated pneumonia, or complicated appendicitis, and discharged to complete a course of antibiotics.
Who may be able to join
- Complicated Pneumonia
- Age 2 months-17 years
- ICD-9 CM codes in any of the 21 diagnosis fields:
- Pneumonia (480.x-483.x, 485.x-487.x) AND
- Pleural effusion (510.0, 510.9, 511.0, 511.1, 511.9) AND
- Billing charge for antibiotics on the first day of hospitalization AND
Show all 17Show fewer
- Primary diagnosis must be either pneumonia or pleural effusion
- Complicated Appendicitis
- Ages 3 years to 17 years
- ICD-9-CM principal diagnosis of appendicitis (540.0, 540.1, 540.0) AND
- ICD-9-CM principal procedure codes of non-incidental appendectomy (470.9, 470.1) AND
- At least 3 unique postop days of antibiotics
- Acute Osteomyelitis
- Ages 2 months- 17 years
- ICD-9-CM codes in any of the 21 diagnosis fields:
- Acute Osteomyelitis (730.01-730.09) OR
- Unspecified Osteomyelitis (730.2-730.29)
Who cannot join
- Complicated Pneumonia • Patients without ED charge (excludes transfers from OSH)
- Complicated Appendicitis
- Patients without ED charge (excludes transfers from OSH and possibility of interval appendectomy that is misclassified)
- Acute Osteomyelitis
- Hospitalization 6 months prior to index admission for chronic osteomyelitis (ICD-9-CM code 730.1)
- ICD9-CM codes for potential confounding comorbidities (e.g. cellulitis, pyogenic arthritis, sacroiliitis, etc.)
About this study
Some children get serious bacterial infections that require hospitalization and then a long course of antibiotics to completely treat the infection. Examples of these serious infections include ruptured appendicitis (when the appendix gets inflamed and bursts, releasing bacteria into the abdomen), complicated pneumonia (when an infected pocket of pus forms either in the lung or between the lung and chest wall), and osteomyelitis (an infection of the bone). To extend the duration of antibiotic therapy after discharge from the hospital, doctors will often insert a long catheter called a PICC line in the child's vein, which can stay in the body for several weeks. However, PICC lines require a fair amount of maintenance and training of caregivers in their use, require children to restrict their activities, and can lead to serious complications, such as blood stream infections and clots. An alternative to PICC lines is extending the duration of antibiotic therapy with oral antibiotics (pills or syrup) that achieve high levels of medicine in the blood and do not have the extra work, inconvenience and risks of PICC lines. Unfortunately, there are very few high quality studies that have demonstrated that oral antibiotics are just as good as intravenous antibiotics delivered via a PICC line, and so many doctors still recommend the PICC line treatment option. Also, no studies have been done to compare the impact of these two treatment options on the quality of life of the child and their caregivers.
In this proposal the investigator outline a series of projects to compare oral antibiotics vs. intravenous antibiotics delivered via a PICC line in children who require prolonged (at least 1 week) home antibiotic therapy after hospitalization for three different serious bacterial infections: ruptured appendicitis, complicated pneumonia, and osteomyelitis. To see whether oral antibiotics are just as good as PICC lines, the investigators will use data collected from over 15,000 children with one of these three infections who were hospitalized at one of 43 US children's hospitals during the years 2009-2011, and determine whether PICC lines resulted in fewer rehospitalizations for treatment failure than oral therapy.
Read the detailed description
Background: When clinicians want to prescribe prolonged antibiotic therapy for children who have been hospitalized with a serious bacterial infection they have two options: (1) discontinue the intravenous antibiotics and discharge the child to receive a prolonged course of oral antibiotics at home; or (2) insert a central venous catheter (usually a peripherally inserted central catheter (PICC)), train the parents in care of the PICC and administration of intravenous antibiotics, and discharge the child to receive a prolonged course of intravenous antibiotics via the central venous catheter at home. These two options have major implications for the overall experience of the child and their caregiver, but there is a paucity of evidence on their comparative effectiveness to help clinicians, patients, and their caregivers make an informed choice.
Objectives: In this proposal the investigators outline a series of projects to compare oral antibiotics vs. intravenous antibiotics delivered via a central venous catheter in children who require prolonged (at least 1 week) home antibiotic therapy after hospitalization for three different serious bacterial infections: perforated appendicitis, complicated pneumonia, and osteomyelitis.
Methods: To compare the clinical effectiveness of these two treatment options, the investigators will conduct three separate retrospective comparative effectiveness studies for each of these diseases using detailed electronic data on diagnoses, procedures, laboratory tests, and orders for drugs and devices supplemented by limited chart review from 43 free standing children's hospitals that are members of the Children's Hospital Association (CHA) (study years 2009-2011, total sample size will exceed 15,000 children). The primary outcome will be rehospitalization for treatment failure. The investigators will use conventional and propensity-score based methods, including matching, to estimate and compare the effect of the two treatment options on patient outcomes. These comparisons will have the goal of asking about the effect of therapy as if the patients had been randomized to one of the two treatment options.
- Conditions
- Osteomyelitis, Pneumonia, Appendicitis
- Being tested
- Peripherally Inserted Central Catheter (PICC)
- Medical subject headings
- Osteomyelitis, Pneumonia, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripherally Inserted Central Catheter (PICC)Device
Post-discharge antibiotics delivered via a PICC line.
| Study group | Role | What they receive |
|---|---|---|
| Acute Osteomyelitis | Not described Receives: Device: Peripherally Inserted Central Catheter (PICC) | |
| Complicated Pneumonia | Not described Receives: Device: Peripherally Inserted Central Catheter (PICC) | |
| Complicated Appendicitis | Not described Receives: Device: Peripherally Inserted Central Catheter (PICC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure
Revisit to the ED or a rehospitalization for a change in the antibiotic prescribed or its dosage, prolongation of antibiotic therapy, conversion from the oral to the PICC route.
Measured: 6 months
Secondary outcomes (2)
PICC complication
Revisit to the ED or a rehospitalization for fever evaluation, infection at the site of the PICC insertion, blood stream infection, sepsis, and thrombosis, breakage, repair, adjustment, manipulation, or removal of the PICC line with or without insertion of a new line.
Measured: 6 months
Adverse Drug Reaction
Return to the ED or a rehospitalization for an adverse drug reaction (defined as vomiting and/or diarrhea, dehydration, Clostridium difficile infection, allergic reaction, urticaria, anaphylaxis, drug- induced neutropenia, acute kidney injury, Stevens-Johnson syndrome, erythema multiforme, or other).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJan 2009
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Boston Children's Hospital, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Ron Keren, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311452
- Sponsor's protocol ID
- 526
- Acronym
- PIVVOT
- Status last verified
- Dec 2014
- First submitted
- 4 Dec 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Intravenous v. Oral Antibiotic Therapy for Serious Bacterial Infections
- ClinicalTrials.gov ID
- NCT02311452
- Acronym / sponsor ID
- PIVVOT / 526
- Conditions
- Osteomyelitis, Pneumonia, Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Utah, Boston Children's Hospital, Children's Hospital Medical Center, Cincinnati
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some children get serious bacterial infections that require hospitalization and then a long course of antibiotics to completely treat the infection. Examples of these serious infections include ruptured appendicitis (when the appendix gets inflamed and bursts, releasing bacteria into the abdomen), complicated pneumonia (when an infected pocket of pus forms either in the lung or between the lung and chest wall), and osteomyelitis (an infection of the bone). To extend the duration of antibiotic therapy after discharge from the hospital, doctors will often insert a long catheter called a PICC line in the child's vein, which can stay in the body for several weeks. However, PICC lines require a fair amount of maintenance and training of caregivers in their use, require children to restrict their activities, and can lead to serious complications, such as blood stream infections and clots. An alternative to PICC lines is extending the duration of antibiotic therapy with oral antibiotics (pills or syrup) that achieve high levels of medicine in the blood and do not have the extra work, inconvenience and risks of PICC lines. Unfortunately, there are very few high quality studies that have demonstrated that oral antibiotics are just as good as intravenous antibiotics delivered via a PICC line, and so many doctors still recommend the PICC line treatment option. Also, no studies have been done to compare the impact of these two treatment options on the quality of life of the child and their caregivers.
In this proposal the investigator outline a series of projects to compare oral antibiotics vs. intravenous antibiotics delivered via a PICC line in children who require prolonged (at least 1 week) home antibiotic therapy after hospitalization for three different serious bacterial infections: ruptured appendicitis, complicated pneumonia, and osteomyelitis. To see whether oral antibiotics are just as good as PICC lines, the investigators will use data collected from over 15,000 children with one of these three infections who were hospitalized at one of 43 US children's hospitals during the years 2009-2011, and determine whether PICC lines resulted in fewer rehospitalizations for treatment failure than oral therapy.
Detailed description
Background: When clinicians want to prescribe prolonged antibiotic therapy for children who have been hospitalized with a serious bacterial infection they have two options: (1) discontinue the intravenous antibiotics and discharge the child to receive a prolonged course of oral antibiotics at home; or (2) insert a central venous catheter (usually a peripherally inserted central catheter (PICC)), train the parents in care of the PICC and administration of intravenous antibiotics, and discharge the child to receive a prolonged course of intravenous antibiotics via the central venous catheter at home. These two options have major implications for the overall experience of the child and their caregiver, but there is a paucity of evidence on their comparative effectiveness to help clinicians, patients, and their caregivers make an informed choice.
Objectives: In this proposal the investigators outline a series of projects to compare oral antibiotics vs. intravenous antibiotics delivered via a central venous catheter in children who require prolonged (at least 1 week) home antibiotic therapy after hospitalization for three different serious bacterial infections: perforated appendicitis, complicated pneumonia, and osteomyelitis.
Methods: To compare the clinical effectiveness of these two treatment options, the investigators will conduct three separate retrospective comparative effectiveness studies for each of these diseases using detailed electronic data on diagnoses, procedures, laboratory tests, and orders for drugs and devices supplemented by limited chart review from 43 free standing children's hospitals that are members of the Children's Hospital Association (CHA) (study years 2009-2011, total sample size will exceed 15,000 children). The primary outcome will be rehospitalization for treatment failure. The investigators will use conventional and propensity-score based methods, including matching, to estimate and compare the effect of the two treatment options on patient outcomes. These comparisons will have the goal of asking about the effect of therapy as if the patients had been randomized to one of the two treatment options.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Osteomyelitis | – | Device: Peripherally Inserted Central Catheter (PICC) |
| Complicated Pneumonia | – | Device: Peripherally Inserted Central Catheter (PICC) |
| Complicated Appendicitis | – | Device: Peripherally Inserted Central Catheter (PICC) |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children hospitalized for acute osteomyelitis, complicated pneumonia, or complicated appendicitis, and discharged to complete a course of antibiotics.
Key inclusion criteria (17 listed)
- Complicated Pneumonia
- Age 2 months-17 years
- ICD-9 CM codes in any of the 21 diagnosis fields:
- Complicated Appendicitis
- Ages 3 years to 17 years
Key exclusion criteria (6 listed)
- Complicated Pneumonia • Patients without ED charge (excludes transfers from OSH)
- Complicated Appendicitis
- Patients without ED charge (excludes transfers from OSH and possibility of interval appendectomy that is misclassified)
- Acute Osteomyelitis
- Hospitalization 6 months prior to index admission for chronic osteomyelitis (ICD-9-CM code 730.1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripherally Inserted Central Catheter (PICC)Post-discharge antibiotics delivered via a PICC line. | Device | Acute Osteomyelitis, Complicated Appendicitis, Complicated Pneumonia |
Primary outcome
Treatment Failure
Time frame: 6 months
Revisit to the ED or a rehospitalization for a change in the antibiotic prescribed or its dosage, prolongation of antibiotic therapy, conversion from the oral to the PICC route.
2 secondary outcomes
PICC complication
Time frame: 6 months
Adverse Drug Reaction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis and Pneumonia, run by Children's Hospital of Philadelphia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.