Streptococcus Pneumoniae InfectionPIMNCT05361499
A Controlled Human Pneumococcal Infection Model (PIM) Study
A study testing Sp_6B and Amoxicillin 500 mg in people with Streptococcus Pneumoniae Infection, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Infection with Streptococcus pneumoniae (the pneumococcus) is the leading cause of pneumonia, bacterial meningitis and bacteraemia worldwide in the very young and the elderly. Although pneumococcal vaccines exist, they do not provide complete protection and new strategies to combat this pathogen are urgently needed. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae Infection
- What is being tested?
- Sp_6B and Amoxicillin 500 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 May 2022to 16 Feb 2023
- Phase
- Interventional
- 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is aged ≥ 18 and < 50 years on the day of the baseline visit.
- Participant is in good health as confirmed by review of medical history and physical examination.
- Participant has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Participant has a home address within the Netherlands.
- Participant is fully conversant in the Dutch language
- Participant is able to communicate easily by both mobile telephone and text messaging
Show all 14Show fewer
- Participant is available to attend all study visits.
- Participant agrees to inform his/her general practitioner (GP), in case applicable, about participation in the study and signs a request to release any relevant medical information concerning possible contra-indications for participation in the study by the GP.
- Participant agrees to provide access to information regarding the vaccination background
- Participant agrees to provide a treating physician access to all study-related information and data in case an adverse event occurs
- Participant is able to arrive within 3h at the Radboudumc at any time during the study participation and participant is able to arrive within 1h at the Radboudumc from his/her home address. The participant must have a home address and live in the Netherlands.
- Participant is willing to take an antibiotic regiment after inoculation with S. pneumoniae according to the study protocol.
- Participant has signed informed consent.
- Participant is able to answer all questions of the pre-consent questionnaire correctly.
Who cannot join
- Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results.
- Smoking: Any smoking event in the last month, including (e-)cigarette, joint, cigar and pipe
- Previous pneumococcal vaccination or infection with the pneumococcus at screening or inclusion visit
- Close physical contact with at risk individuals, i.e. children under 5 years of age, immunosuppressed adults, frail elderly, chronically ill individuals. Close physical contact is defined as:
- living in the same household
- having work-related contact
Show all 15Show fewer
- spending more than 1 hour/day together with an at risk individual at less than 1.5 meter distance.
- Illness at screening visit, illness at baseline (including mild upper respiratory tract infection, common cold, running nose), acute illness within 3 days prior to inoculation
- Any antibiotic treatment within 2 weeks before inoculation
- For female participants: pregnancy, lactation or intention to become pregnant during the study. Female volunteers are required to use an effective form of contraception during this study.
- Known hypersensitivity to or contra-indications (including co-medication) for use of penicillin
- Receipt of any vaccinations in the two weeks prior to the start of the study (inoculation) or plans to receive any other vaccinations during the study period.
- Participation in any other clinical study (unless observational) in the three months prior to the start of the study or during the study period.
- Being an employee or student of the department of Laboratory Medicine, Radboudumc.
- Any other condition or situation that would, in the opinion of the investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Infection with Streptococcus pneumoniae (the pneumococcus) is the leading cause of pneumonia, bacterial meningitis and bacteraemia worldwide in the very young and the elderly. Although pneumococcal vaccines exist, they do not provide complete protection and new strategies to combat this pathogen are urgently needed. Asymptomatic infection of S. pneumoniae in the human nasopharynx precedes the development of pneumococcal disease. Previously, an Experimental Human Pneumococcal Carriage (EHPC) model has been developed at the Liverpool School of Tropical Medicine (LSTM). The current study entails to establish this model in healthy adults living in the Netherlands using the inoculation dose currently used at LSTM.
Healthy adult participants (M/F) will be inoculated intranasally with strain BHN418, a penicillin sensitive serotype 6B strain of S. pneumoniae that was previously isolated from a healthy carrier. Following inoculation, participants will be monitored and blood and nasal samples will be collected over a period of 28 ± 3 days. Participants will receive a course of amoxicillin to eradicate infection on or shortly after the last visit at day 28 ± 3, unless S. pneumoniae is not detected on both day 14 and 28 ± 3 post-inoculation.
- Conditions
- Streptococcus Pneumoniae Infection
- Being tested
- Sp_6B, Amoxicillin 500 mg
- Keywords
- Controlled human infection model, Streptococcus pneumoniae, Asymptomatic infection, Colonization, Healthy adults
- Medical subject headings
- Pneumococcal Infections, Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sp_6BBiological
Intranasal inoculation of Streptococcus pneumoniae serotype 6B, 160,000 colony forming units (CFU)
Amoxicillin 500 mgDrug
Amoxicillin, 7 days, 2x 500 mg
| Study group | Role | What they receive |
|---|---|---|
| Streptococcus pneumoniae 6B (Sp_6B) inoculated | Experimental | Not described Receives: Biological: Sp_6B; Drug: Amoxicillin 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of volunteers infected with S. pneumoniae serotype 6B following inoculation.
Measured: up to 4 weeks after inoculation
Secondary outcomes (5)
The number of participants with sollicited AEs that are related to infection
Measured: from the baseline visit (between day -1 and -6) till the end of the study (day 28 ± 3)
The number, type and severity of sollicited AEs that are related to infection
Measured: from the baseline visit (between day -1 and -6) till the end of the study (day 28 ± 3)
Number of sampling timepoints with S. pneumoniae culture-positive nasal wash samples post-inoculation
Measured: On day 3, 7, 14 and 28 after inoculation
Number of colony forming units (CFUs) per ml detected in nasal wash of infected participants at each sampling timepoint
Measured: On day 3, 7, 14 and 28 after inoculation
Concentrations of S. pneumoniae-specific antibodies in blood and mucosal samples at the various sampling time points
Measured: On day 3, 7, 14 and 28 after inoculation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start31 May 2022
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Pneumoniae InfectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single dose open label intervention study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361499
- Sponsor's protocol ID
- NL79171.091.22
- Acronym
- PIM
- Status last verified
- Apr 2022
- First submitted
- 29 Apr 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Human Pneumococcal Infection Model (PIM) Study
- ClinicalTrials.gov ID
- NCT05361499
- Acronym / sponsor ID
- PIM / NL79171.091.22
- Conditions
- Streptococcus Pneumoniae Infection
- Keywords
- Controlled human infection model, Streptococcus pneumoniae, Asymptomatic infection, Colonization, Healthy adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 4 May 2022 (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.
Infection with Streptococcus pneumoniae (the pneumococcus) is the leading cause of pneumonia, bacterial meningitis and bacteraemia worldwide in the very young and the elderly. Although pneumococcal vaccines exist, they do not provide complete protection and new strategies to combat this pathogen are urgently needed. Asymptomatic infection of S. pneumoniae in the human nasopharynx precedes the development of pneumococcal disease. Previously, an Experimental Human Pneumococcal Carriage (EHPC) model has been developed at the Liverpool School of Tropical Medicine (LSTM). The current study entails to establish this model in healthy adults living in the Netherlands using the inoculation dose currently used at LSTM.
Healthy adult participants (M/F) will be inoculated intranasally with strain BHN418, a penicillin sensitive serotype 6B strain of S. pneumoniae that was previously isolated from a healthy carrier. Following inoculation, participants will be monitored and blood and nasal samples will be collected over a period of 28 ± 3 days. Participants will receive a course of amoxicillin to eradicate infection on or shortly after the last visit at day 28 ± 3, unless S. pneumoniae is not detected on both day 14 and 28 ± 3 post-inoculation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single dose open label intervention study
| Arm | Type | Receives |
|---|---|---|
| Streptococcus pneumoniae 6B (Sp_6B) inoculated | Experimental | Biological: Sp_6B, Drug: Amoxicillin 500 mg |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Participant is aged ≥ 18 and < 50 years on the day of the baseline visit.
- Participant is in good health as confirmed by review of medical history and physical examination.
- Participant has adequate understanding of the procedures of the study and agrees to abide strictly thereby.
- Participant has a home address within the Netherlands.
- Participant is fully conversant in the Dutch language
Key exclusion criteria (15 listed)
- Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results.
- Smoking: Any smoking event in the last month, including (e-)cigarette, joint, cigar and pipe
- Previous pneumococcal vaccination or infection with the pneumococcus at screening or inclusion visit
- Close physical contact with at risk individuals, i.e. children under 5 years of age, immunosuppressed adults, frail elderly, chronically ill individuals. Close physical contact is defined as:
- Illness at screening visit, illness at baseline (including mild upper respiratory tract infection, common cold, running nose), acute illness within 3 days prior to inoculation
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 |
|---|---|---|
| Sp_6BIntranasal inoculation of Streptococcus pneumoniae serotype 6B, 160,000 colony forming units (CFU) | Biological | Streptococcus pneumoniae 6B (Sp_6B) inoculated |
| Amoxicillin 500 mgAmoxicillin, 7 days, 2x 500 mg | Drug | Streptococcus pneumoniae 6B (Sp_6B) inoculated |
Primary outcome
Percentage of volunteers infected with S. pneumoniae serotype 6B following inoculation.
Time frame: up to 4 weeks after inoculation
5 secondary outcomes
The number of participants with sollicited AEs that are related to infection
Time frame: from the baseline visit (between day -1 and -6) till the end of the study (day 28 ± 3)
The number, type and severity of sollicited AEs that are related to infection
Time frame: from the baseline visit (between day -1 and -6) till the end of the study (day 28 ± 3)
Number of sampling timepoints with S. pneumoniae culture-positive nasal wash samples post-inoculation
Time frame: On day 3, 7, 14 and 28 after inoculation
Number of colony forming units (CFUs) per ml detected in nasal wash of infected participants at each sampling timepoint
Time frame: On day 3, 7, 14 and 28 after inoculation
Concentrations of S. pneumoniae-specific antibodies in blood and mucosal samples at the various sampling time points
Time frame: On day 3, 7, 14 and 28 after inoculation
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 22 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Streptococcus Pneumoniae Infection
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingPhase 3
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pneumococcal Disease
Active, not recruitingPhase 1
A Study to Understand the Safety of the 20vPnC Vaccine in Healthy Chinese Adults, Children, and Infant
Pneumococcal Disease
Enrolling by invitation
Randomized Controlled Trial Of Text Messages To Increase Pneumococcal Vaccination In Adults In Chile.
Pneumococcal Infections, Immunization Programs
Not yet recruitingPhase 4
Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer
Pneumococcal Polysaccharide Vaccine, Influenza Vaccines
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?
A study testing Sp_6B and Amoxicillin 500 mg in people with Streptococcus Pneumoniae Infection, run by Radboud University Medical Center at 1 site in Netherlands.
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 14 inclusion and 15 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 22 Feb 2023. 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 Netherlands. 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?
Percentage of volunteers infected with S. pneumoniae serotype 6B following inoculation. (time frame: up to 4 weeks after inoculation). 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 22 Feb 2023.