Streptococcal PneumoniaPCVNCT03331952
A Study of Streptococcus Pneumonia Colonisation and Invasive Disease in Cambodian Children
An observational study of Streptococcal Pneumonia, run by University of Oxford at 1 site in Cambodia.
Trial summary
Streptococcus pneumoniae (the pneumococcus) remains a leading cause of childhood mortality and morbidity. Between 2007 and 2012, Angkor Hospital for Children (AHC), Siem Reap, Cambodia documented that S. Read more about this study
- Who is it for?
- Ages 0 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Streptococcal Pneumonia
- What is being tested?
- Prospective study and Cross-sectional surveys
- Type of treatment
- Vaccines
- How many people
- 4,111 participants
- Where
- 1 siteCambodia
- Study dates
- 3 Aug 2015to 19 Oct 2018
- 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 0 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Group1: This is a prospective study to identify and characterise patients with culture proven invasive pneumococcal disease or probable bacterial meningitis over the first three years after PCV13 introduction in Cambodia in January 2015. Group2: This is a prospective study to identify and characterise patients hospitalised with clinical and/or radiologic pneumonia over the first three years after PCV13 introduction in Cambodia in January 2015. Group3: Three annual surveys, enrolling 450 children each year, will be done to identify and characterise pneumococcal nasopharyngeal colonisation in AHC out-patient department (OPD) attendees.
Who may be able to join
- Age: 0 - 59 months on the day of assessment / culture AND
- S.pneumoniae identified from a normally sterile site culture. OR
- WHO Coordinated Invasive Bacterial Vaccine Preventable Diseases (IB-VPD) Surveillance Network Case Definition for probable bacterial meningitis. Clinically suspected meningitis and a CSF examination with at least one of:
- Turbid appearance.
- Leucocytosis (WBC count of >100 cells/mm3).
- Leucocytosis (10-100 cells/mm3) AND either an elevated protein (>100 mg/dL) or decreased glucose (<2.2 mmol/L).
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- Age: 0 - 59 months on the day of admission AND
- Admission to the IPD, ER/ICU, or NICU/SCBU. AND
- Meets the WHO Coordinated Invasive Bacterial Vaccine Preventable Diseases (IB-VBD) Surveillance Network pneumonia / severe pneumonia case definition:
- Cough and/or difficulty breathing. AND
- Tachypnoea OR
- Inability to breast feed or drink.
- Vomiting everything.
- Convulsions.
- Prostration/lethargy.
- Chest indrawing.
- Stridor when calm.
- Age: 0 - 59 months on the day of recruitment
Who cannot join
- Previous enrolment within the last 14 days.
- Parent / guardian or caretaker refused consent.
- Group2: PCV-P
- Previous enrolment within the last 14 days.
- Parent / guardian or caretaker refused consent.
- Group3: PCV-C
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- Parent / guardian or caretaker reports symptoms of potential acute lower respiratory tract illness.
- Triage nurse selects child for doctor review / hospital admission.
- Previous enrolment in the current annual survey.
- Parent / guardian or caretaker refused consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Pneumococcal Conjugate Vaccine Introduction in Cambodia: A Study of Streptococcus Pneumoniae Colonisation, Pneumonia and Invasive Disease in Cambodian Children
Streptococcus pneumoniae (the pneumococcus) remains a leading cause of childhood mortality and morbidity. Between 2007 and 2012, Angkor Hospital for Children (AHC), Siem Reap, Cambodia documented that S. pneumoniae was responsible for around 10% of bloodstream infections in hospitalised children, with a case fatality rate of 15.6%.
The use of pneumococcal conjugate vaccines (PCV), covering between 7 and 13 of the >90 pneumococcal serotypes, has resulted in significant declines in invasive pneumococcal disease (IPD) incidence in countries where they are included in routine childhood immunisation schedules. Paediatric radiologic pneumonia incidence is also reduced by PCV, but the impact on clinical pneumonia is minimal. The vaccines have had an effect on reducing the burden of drug resistant IPD, although this may not be sustained. Given the large number of serotypes not included in the current PCV formulations, it is not surprising that initial declines in overall IPD incidence have been eroded by, for the time being, small increases in IPD due to non-vaccine serotypes. To date most data on this serotype replacement disease has come from high-income countries. It less clear how much serotype replacement will occur in low and middle income countries, where pre-PCV disease incidence is generally higher and other factors, such as unregulated antimicrobial consumption, may play a role in encouraging non-vaccine serotype infections.
Read more
Nasopharyngeal colonisation by S. pneumoniae is common in childhood and is an essential prerequisite for invasive disease. Surveillance of pneumococcal colonisation can provide important data regarding serotype replacement and disease-associated serotypes, and may also allow prediction of likely IPD incidence changes post-vaccine introduction. A recent study of pneumococcal colonisation in children attending the AHC out-patients has documented an overall colonisation prevalence of approximately 65%.
In January 2015, Cambodia will introduce the 13-valent PCV (PCV13; serotypes covered 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 23F). The vaccine will be rolled out nationally with a 3+0 dosing schedule (6, 10 and 14 weeks) and no catch up campaign. There is no robust national surveillance system in place to monitor the effects of PCV13 introduction.
- Conditions
- Streptococcal Pneumonia
- Being tested
- Prospective study, Cross-sectional surveys
- Keywords
- Streptococcal Pneumonia, Pneumococcal Conjugate Vaccine
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective studyOther
To identify and characterise patients with culture proven invasive pneumococcal disease or probable bacterial meningitis over the first three years after PCV13 introduction in Cambodia in January 2015.
Prospective studyOther
To identify and characterise patients hospitalised with clinical and/or radiologic pneumonia over the first three years after PCV13 introduction in Cambodia in January 2015
Cross-sectional surveysOther
Three annual surveys, enrolling 450 children each year, will be done to identify and characterise pneumococcal nasopharyngeal colonisation in AHC out-patient department (OPD) attendees
| Study group | Role | What they receive |
|---|---|---|
| Invasive pneumococcal disease study (PCV-D) | Prospective study of children with invasive pneumococcal disease / probable bacterial meningitis (PCV-D)
Clinical procedures
At study enrolment:
* Admission clinical findings / laboratory results will be recorded.
* A questionnaire will be administered to the parent / guardian or caretaker to assess the child's immunisation status, household structure, environmental exposures, and recent antimicrobial use.
Radiology procedures As part of routine clinical management at AHC, a digital chest radiograph (CXR) may be performed as part of a child's diagnostic work up. CXRs will be read and interpreted primarily by the AHC radiologists. All CXR will subsequently be re-read by two study clinicians and interpreted according to the WHO paediatric radiologic pneumonia criteria.
Laboratory procedures
• Residual routine clinical specimens further analysed as part of the study protocol:
* Blood and cerebrospinal fluid culture specimens.
* EDTA / serum specimens.
* Urine. Receives: Other: Prospective study | |
| Pneumonia study (PCV-P) | Prospective study of children hospitalised with clinical and/or radiologic pneumonia (PCV-P)
Clinical procedures As described for PCV-D.
Radiology procedures As part of routine clinical management at AHC, a digital chest radiograph (CXR) is performed on all children with an admission diagnosis of pneumonia. CXRs will be handled as described for PCV-D.
Laboratory procedures
* Study specific specimens:
o Nasopharyngeal swab at enrolment.
* Residual routine clinical specimens further analysed as part of the study protocol:
* As described for PCV-D. Receives: Other: Prospective study | |
| Pneumococcal colonisation study (PCV-C) | Cross-sectional pneumococcal colonisation surveys in children attending the AHC out-patient department (PCV-C)
Three annual surveys, enrolling 450 children each year, will be done to identify and characterise pneumococcal nasopharyngeal colonisation in AHC out-patient department (OPD) attendees.
Clinical procedures
• Subjects will be recruited from the OPD waiting area after nurse triage. A questionnaire will be administered to the parent / guardian or caretaker to assess the child's immunisation status (by review of the handheld immunisation card where possible), household structure, environmental exposures, and recent antimicrobial use.
Laboratory procedures • Study specific specimens:
o Nasopharyngeal swab at enrolment. A nasopharyngeal swab will be collected from each participant and these will be processed as described for PCV-P. Receives: Other: Cross-sectional surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive pneumococcal disease hospitalisation rates
Measured: 3 years
Characteristics of invasive S. pneumoniae isolates in children <5 years of age admitted to Angkor Hospital for Children, in relation to national introduction of PCV13 in Cambodia
Measured: 3 years
Secondary outcomes (6)
Changes in pneumonia (both clinical and radiologic) hospitalisation rates in children <5 years of age, in relation to national introduction of PCV13 in Cambodia
Measured: 3 years
Pneumococcal colonisation prevalence
Measured: 3 years
Antimicrobial susceptibility profiles in relation to national introduction of PCV13
Measured: 3 years
Serotype in relation to national introduction of PCV13
Measured: 3 years
Genotype in relation to national introduction of PCV13
Measured: 3 years
Compare pneumococcal serotype colonisation in pneumonia cases with children attending the hospital out-patients for minor illnesses
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start3 Aug 2015
- Primary completion31 Aug 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal PneumoniaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Prospective
- Enrolment
- 4,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331952
- Sponsor's protocol ID
- COMRU1501
- Acronym
- PCV
- Status last verified
- Oct 2020
- First submitted
- 1 Nov 2017
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Pneumococcal Conjugate Vaccine Introduction in Cambodia: A Study of Streptococcus Pneumoniae Colonisation, Pneumonia and Invasive Disease in Cambodian Children
- ClinicalTrials.gov ID
- NCT03331952
- Acronym / sponsor ID
- PCV / COMRU1501
- Conditions
- Streptococcal Pneumonia
- Keywords
- Streptococcal Pneumonia, Pneumococcal Conjugate Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,111 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 3 Aug 2015 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
Streptococcus pneumoniae (the pneumococcus) remains a leading cause of childhood mortality and morbidity. Between 2007 and 2012, Angkor Hospital for Children (AHC), Siem Reap, Cambodia documented that S. pneumoniae was responsible for around 10% of bloodstream infections in hospitalised children, with a case fatality rate of 15.6%.
The use of pneumococcal conjugate vaccines (PCV), covering between 7 and 13 of the >90 pneumococcal serotypes, has resulted in significant declines in invasive pneumococcal disease (IPD) incidence in countries where they are included in routine childhood immunisation schedules. Paediatric radiologic pneumonia incidence is also reduced by PCV, but the impact on clinical pneumonia is minimal. The vaccines have had an effect on reducing the burden of drug resistant IPD, although this may not be sustained. Given the large number of serotypes not included in the current PCV formulations, it is not surprising that initial declines in overall IPD incidence have been eroded by, for the time being, small increases in IPD due to non-vaccine serotypes. To date most data on this serotype replacement disease has come from high-income countries. It less clear how much serotype replacement will occur in low and middle income countries, where pre-PCV disease incidence is generally higher and other factors, such as unregulated antimicrobial consumption, may play a role in encouraging non-vaccine serotype infections.
Nasopharyngeal colonisation by S. pneumoniae is common in childhood and is an essential prerequisite for invasive disease. Surveillance of pneumococcal colonisation can provide important data regarding serotype replacement and disease-associated serotypes, and may also allow prediction of likely IPD incidence changes post-vaccine introduction. A recent study of pneumococcal colonisation in children attending the AHC out-patients has documented an overall colonisation prevalence of approximately 65%.
In January 2015, Cambodia will introduce the 13-valent PCV (PCV13; serotypes covered 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 23F). The vaccine will be rolled out nationally with a 3+0 dosing schedule (6, 10 and 14 weeks) and no catch up campaign. There is no robust national surveillance system in place to monitor the effects of PCV13 introduction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Invasive pneumococcal disease study (PCV-D) | – | Other: Prospective studyProspective study of children with invasive pneumococcal disease / probable bacterial meningitis (PCV-D) Clinical procedures At study enrolment: * Admission clinical findings / laboratory results will be recorded. * A questionnaire will be administered to the parent / guardian or caretaker to assess the child's immunisation status, household structure, environmental exposures, and recent antimicrobial use. Radiology procedures As part of routine clinical management at AHC, a digital chest radiograph (CXR) may be performed as part of a child's diagnostic work up. CXRs will be read and interpreted primarily by the AHC radiologists. All CXR will subsequently be re-read by two study clinicians and interpreted according to the WHO paediatric radiologic pneumonia criteria. Laboratory procedures • Residual routine clinical specimens further analysed as part of the study protocol: * Blood and cerebrospinal fluid culture specimens. * EDTA / serum specimens. * Urine. |
| Pneumonia study (PCV-P) | – | Other: Prospective studyProspective study of children hospitalised with clinical and/or radiologic pneumonia (PCV-P) Clinical procedures As described for PCV-D. Radiology procedures As part of routine clinical management at AHC, a digital chest radiograph (CXR) is performed on all children with an admission diagnosis of pneumonia. CXRs will be handled as described for PCV-D. Laboratory procedures * Study specific specimens: o Nasopharyngeal swab at enrolment. * Residual routine clinical specimens further analysed as part of the study protocol: * As described for PCV-D. |
| Pneumococcal colonisation study (PCV-C) | – | Other: Cross-sectional surveysCross-sectional pneumococcal colonisation surveys in children attending the AHC out-patient department (PCV-C) Three annual surveys, enrolling 450 children each year, will be done to identify and characterise pneumococcal nasopharyngeal colonisation in AHC out-patient department (OPD) attendees. Clinical procedures • Subjects will be recruited from the OPD waiting area after nurse triage. A questionnaire will be administered to the parent / guardian or caretaker to assess the child's immunisation status (by review of the handheld immunisation card where possible), household structure, environmental exposures, and recent antimicrobial use. Laboratory procedures • Study specific specimens: o Nasopharyngeal swab at enrolment. A nasopharyngeal swab will be collected from each participant and these will be processed as described for PCV-P. |
Who may qualify
- Ages
- 0 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Group1: This is a prospective study to identify and characterise patients with culture proven invasive pneumococcal disease or probable bacterial meningitis over the first three years after PCV13 introduction in Cambodia in January 2015. Group2: This is a prospective study to identify and characterise patients hospitalised with clinical and/or radiologic pneumonia over the first three years after PCV13 introduction in Cambodia in January 2015. Group3: Three annual surveys, enrolling 450 children each year, will be done to identify and characterise pneumococcal nasopharyngeal colonisation in AHC out-patient department (OPD) attendees.
Key inclusion criteria (18 listed)
- Age: 0 - 59 months on the day of assessment / culture AND
- S.pneumoniae identified from a normally sterile site culture. OR
- WHO Coordinated Invasive Bacterial Vaccine Preventable Diseases (IB-VPD) Surveillance Network Case Definition for probable bacterial meningitis. Clinically suspected meningitis and a CSF examination with at least one of:
- Age: 0 - 59 months on the day of admission AND
- Admission to the IPD, ER/ICU, or NICU/SCBU. AND
Key exclusion criteria (10 listed)
- Previous enrolment within the last 14 days.
- Parent / guardian or caretaker refused consent.
- Group2: PCV-P
- Previous enrolment within the last 14 days.
- Parent / guardian or caretaker refused consent.
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 |
|---|---|---|
| Prospective studyTo identify and characterise patients with culture proven invasive pneumococcal disease or probable bacterial meningitis over the first three years after PCV13 introduction in Cambodia in January 2015. | Other | Invasive pneumococcal disease study (PCV-D) |
| Prospective studyTo identify and characterise patients hospitalised with clinical and/or radiologic pneumonia over the first three years after PCV13 introduction in Cambodia in January 2015 | Other | Pneumonia study (PCV-P) |
| Cross-sectional surveysThree annual surveys, enrolling 450 children each year, will be done to identify and characterise pneumococcal nasopharyngeal colonisation in AHC out-patient department (OPD) attendees | Other | Pneumococcal colonisation study (PCV-C) |
Primary outcome
Invasive pneumococcal disease hospitalisation rates
Time frame: 3 years
Characteristics of invasive S. pneumoniae isolates in children <5 years of age admitted to Angkor Hospital for Children, in relation to national introduction of PCV13 in Cambodia
Time frame: 3 years
6 secondary outcomes
Changes in pneumonia (both clinical and radiologic) hospitalisation rates in children <5 years of age, in relation to national introduction of PCV13 in Cambodia
Time frame: 3 years
Pneumococcal colonisation prevalence
Time frame: 3 years
Antimicrobial susceptibility profiles in relation to national introduction of PCV13
Time frame: 3 years
Serotype in relation to national introduction of PCV13
Time frame: 3 years
Genotype in relation to national introduction of PCV13
Time frame: 3 years
Compare pneumococcal serotype colonisation in pneumonia cases with children attending the hospital out-patients for minor illnesses
Time frame: 3 years
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 9 Oct 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcal Pneumonia, run by University of Oxford at 1 site in Cambodia.
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 18 inclusion and 10 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 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Invasive pneumococcal disease hospitalisation rates (time frame: 3 years). The study lists 2 primary outcomes in all. 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 9 Oct 2020.