Cy-Tb for Detecting Mycobacterium Tuberculosis Infection in Indonesian Population
NCT07929285, Not applicable, Not yet recruiting, PT Bio Farma
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cy-Tb for Detecting Mycobacterium Tuberculosis Infection in Indonesian Population | ClinicalTrials.gov |
| NCT number | NCT07929285 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 350 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | PT Bio Farma | ClinicalTrials.gov |
| Conditions | TB Infection | ClinicalTrials.gov |
| Interventions | Cy-Tb test, IGRA test | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Positive coincidence rate of Cy-Tb in comparison to IGRA test in identifying TB infection | 48-72 hours | The induration should be measured 48-72 hours after the injection. Measure the diameter of the induration transversely to the long axis of the forearm with a caliper. Normally the induration and erythema will decrease after 4 days and disappear within 28 days after the injection. An induration of ≥ 5 mm in Cy-Tb is considered as a positive result, which indicates infection with Mycobacterium tuberculosis. The induration can be seen as a raised area with clearly defined margin at and around the injection site. Although erythema can accompany the induration, only the induration should be measured. The main trial objectives were to compare the positive coincidence rate of Cy-Tb to IGRA test in identifying TB infection. | ClinicalTrials.gov |
| Secondary | Negative coincidence rate of Cy-Tb in comparison to IGRA test in identifying TB infection | 48-72 hours | The proportion of participants with a positive Cy-Tb test result (induration ≥5 mm) compared with the IGRA test result in identifying Mycobacterium tuberculosis infection. The Cy-Tb induration will be measured transversely to the long axis of the forearm using a caliper. Only induration will be measured, excluding erythema. | ClinicalTrials.gov |
| Secondary | Adverse events within 28 days after Cy-Tb test | 28 days | The number and proportion of participants experiencing adverse events following Cy-Tb administration within 28 days after injection. Adverse events will be monitored and recorded throughout the 28-day follow-up period, including the occurrence, severity, duration, and relationship to Cy-Tb administration, where applicable. | ClinicalTrials.gov |
| Secondary | Incremental Cost-Effectiveness Ratio | 28 days | The incremental cost-effectiveness ratio (ICER) will be calculated by comparing the difference in costs between Cy-Tb and IGRA with the difference in their effectiveness in identifying Mycobacterium tuberculosis infection. The ICER represents the additional cost required to achieve one additional unit of effectiveness when using Cy-Tb compared with IGRA. | ClinicalTrials.gov |
| Secondary | Agreement rate between Cy-Tb and IGRA test in identifying TB infection | 1 month | The proportion of participants with concordant results between the Cy-Tb test and IGRA test in identifying Mycobacterium tuberculosis infection. Agreement will be assessed by comparing the positive and negative results of both tests. The agreement rate will be calculated as the number of participants with concordant test results divided by the total number of participants tested with both methods, expressed as a percentage. | ClinicalTrials.gov |
| Secondary | Incidence of adverse events | 28 days | The incidence and proportion of participants experiencing adverse events following Cy-Tb administration. Adverse events will be recorded, including their type, frequency, severity, duration, and relationship to Cy-Tb administration, where applicable. | ClinicalTrials.gov |
| Secondary | Immediate adverse events within 30 minutes after Cy-Tb test | 30 minutes | The number and proportion of participants experiencing immediate adverse events within 30 minutes after Cy-Tb intradermal injection. Participants will be monitored for any immediate adverse events, including local or systemic reactions, during the 30-minute observation period. | ClinicalTrials.gov |
| Secondary | Serious adverse events within 28 days after Cy-Tb test | 28 days | The number and proportion of participants experiencing serious adverse events (SAEs) within 28 days after Cy-Tb administration. Serious adverse events will be assessed based on their seriousness, including events resulting in death, life-threatening conditions, hospitalization or prolongation of existing hospitalization, persistent or significant disability, or congenital anomalies. The relationship between the serious adverse events and Cy-Tb administration will also be assessed. | ClinicalTrials.gov |
| Other | Acceptability of Cy-Tb test in identifying TB infection in TB close contacts and households | 28 days | The acceptability of the Cy-Tb test among tuberculosis (TB) close contacts and household contacts will be assessed based on participants' willingness to undergo the test, completion of the test procedure, and willingness to undergo the test again if needed. Acceptability will be evaluated using participant responses collected during the study. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)