Safety IssuesPhase 4NCT06053853
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
A Phase 4 study testing Diphtheria Antitoxin in people with Safety Issues, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Safety Issues
- What is being tested?
- Diphtheria Antitoxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndonesia
- Study dates
- 31 Jan 2023to 23 May 2023
- Phase
- Phase 4
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with a probable diagnosis or laboratory confirmation of Diphtheria.
- Subjects who received therapy with the intended DAT
Who cannot join
- Receiving a different brand of Diphtheria Antitoxin (DAT)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia
The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
Read the detailed description
To assess the occurrence of serum sickness after Diphtheria Antitoxin administration.
To assess local and systemic reactions within 24 hours to 10 days. To assess the occurrence of positive reactions after the sensitivity test (skin test). To assess the presence of SAE after Diphtheria Antitoxin administration.
- Conditions
- Safety Issues
- Being tested
- Diphtheria Antitoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphtheria AntitoxinBiological
Dosage form: Solution for injection
Dosage:
- Perform sensitivity tests, and desensitization if necessary.
- Give the entire treatment dose of antitoxin IV (or IM) in a single administration (except for series of injections needed for desensitization).
- The recommended DAT treatment dosage ranges (pediatric and adult) are:
- Pharyngeal or laryngeal disease of 2 days duration 20,000 - 40,000 unit
- Nasopharyngeal disease 40,000 - 60,000 unit
- Extensive disease of 3 or more days duration, or any patient with diffuse swelling of neck 80,000 - 100,000 unit
- Skin lesions only (rare case where treatment is indicated) 20,000 - 40,000 unit
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | Diphtheria Antitoxin (DAT)
Administered intravenously.
Dosage:
* Mild diphtheria (nose, skin): 20,000 unit
* Moderate diphtheria (tonsil - limited): 40,000 - 60,000 unit
* Severe diphtheria (more than 1 tonsil, or to the pharyngeal wall, or more than 5 days of illness, or with bull neck): 80,000 - 120,000 unit Receives: Biological: Diphtheria Antitoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)
Percentage of serum sickness after administration of Diphtheria Antitoxin (DAT)
Measured: Within 10 days after injection
Secondary outcomes (3)
The occurrence of local and systemic reactions after administration of Diphtheria Antitoxin (DAT)
Percentage of local and systemic reaction after administration of Diphtheria Antitoxin (DAT)
Measured: Within 24 hours to 10 days after injection
The occurrence of positive reaction after a sensitivity test (skin test) of Diphtheria Antitoxin (DAT)
Percentage of positive reaction after sensitivity test (skin test) of Diphtheria Antitoxin (DAT)
Measured: Before injection of Diphtheria Antitoxin
The occurrence of serious adverse event (SAE) after administration of Diphtheria Antitoxin (DAT)
Percentage of serious adverse event (SAE) after administration of Diphtheria Antitoxin (DAT)
Measured: Within 10 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start31 Jan 2023
- Primary completion13 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominicus Husada, MD, Principal investigator, Dr. Soetomo Hospital, Surabaya, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053853
- Sponsor's protocol ID
- DAT 0422
- Status last verified
- Nov 2023
- First submitted
- 19 Sep 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia
- ClinicalTrials.gov ID
- NCT06053853
- Acronym / sponsor ID
- DAT 0422
- Conditions
- Safety Issues
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 13 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 26 Sep 2023 (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.
The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
Detailed description
To assess the occurrence of serum sickness after Diphtheria Antitoxin administration.
To assess local and systemic reactions within 24 hours to 10 days. To assess the occurrence of positive reactions after the sensitivity test (skin test). To assess the presence of SAE after Diphtheria Antitoxin administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Biological: Diphtheria AntitoxinDiphtheria Antitoxin (DAT) Administered intravenously. Dosage: * Mild diphtheria (nose, skin): 20,000 unit * Moderate diphtheria (tonsil - limited): 40,000 - 60,000 unit * Severe diphtheria (more than 1 tonsil, or to the pharyngeal wall, or more than 5 days of illness, or with bull neck): 80,000 - 120,000 unit |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with a probable diagnosis or laboratory confirmation of Diphtheria.
- Subjects who received therapy with the intended DAT
Key exclusion criteria (1 listed)
- Receiving a different brand of Diphtheria Antitoxin (DAT)
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 |
|---|---|---|
| Diphtheria AntitoxinDosage form: Solution for injection Dosage: 1. Perform sensitivity tests, and desensitization if necessary. 2. Give the entire treatment dose of antitoxin IV (or IM) in a single administration (except for series of injections needed for desensitization). 3. The recommended DAT treatment dosage ranges (pediatric and adult) are: * Pharyngeal or laryngeal disease of 2 days duration 20,000 - 40,000 unit * Nasopharyngeal disease 40,000 - 60,000 unit * Extensive disease of 3 or more days duration, or any patient with diffuse swelling of neck 80,000 - 100,000 unit * Skin lesions only (rare case where treatment is indicated) 20,000 - 40,000 unit | Biological | Investigational Product |
Primary outcome
The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)
Time frame: Within 10 days after injection
Percentage of serum sickness after administration of Diphtheria Antitoxin (DAT)
3 secondary outcomes
The occurrence of local and systemic reactions after administration of Diphtheria Antitoxin (DAT)
Time frame: Within 24 hours to 10 days after injection
The occurrence of positive reaction after a sensitivity test (skin test) of Diphtheria Antitoxin (DAT)
Time frame: Before injection of Diphtheria Antitoxin
The occurrence of serious adverse event (SAE) after administration of Diphtheria Antitoxin (DAT)
Time frame: Within 10 days after injection
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 18 Nov 2023.
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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.
Dominicus Husada, MD principal investigator
Dr. Soetomo Hospital, Surabaya, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diphtheria Antitoxin in people with Safety Issues, run by PT Bio Farma at 1 site in Indonesia.
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 2 inclusion and 1 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 18 Nov 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 Indonesia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT) (time frame: Within 10 days after injection). 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 18 Nov 2023.