Diarrheal DiseasesPhase 2/3NCT02512614
Evaluation of Novel Antimicrobial Hand Towels
A Phase 2/3 study testing Antimicrobial Hand Towel in people with Diarrheal Diseases and Acute Respiratory Infections, run by Centers for Disease Control and Prevention.
Trial summary
In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diarrheal Diseases, Acute Respiratory Infections, Fever
- What is being tested?
- Antimicrobial Hand Towel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Apr 2013
- Phase
- Phase 2/3
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother of a child <2 years old
Who cannot join
- Inaccessible enumeration area in the rainy season
- Multiple eligible children in a single compound
- Moved between census and round 1
About this study
In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections, self-reported fever, and skin infections in children <2 years old.
Read the detailed description
In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections (ARIs), self-reported fever, and skin infections in children <2 years old.
- Being tested
- Antimicrobial Hand Towel
- Medical subject headings
- Fever, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial Hand TowelOther
Novel antimicrobial hand towel.
| Study group | Role | What they receive |
|---|---|---|
| Comparison | No intervention | Hand hygiene education. |
| Intervention | Experimental | Hand hygiene education and 4 antimicrobial hand towels Receives: Other: Antimicrobial Hand Towel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with diarrheal disease
The number of participants that experience 3 or more loose or watery stools
Measured: Within 48 hours of enrollment
Secondary outcomes (3)
Number of participants with respiratory infections
Measured: Within 48 hours of enrollment
Number of participants with a subjective fever
Measured: Within 48 hours of enrollment
Number of participants with a skin infection
Measured: Within 48 hours of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrheal DiseasesStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512614
- Sponsor's protocol ID
- CDC-NCEZID-6102
- Status last verified
- Jul 2015
- First submitted
- 24 Jun 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Antimicrobial Hand Towels
- ClinicalTrials.gov ID
- NCT02512614
- Acronym / sponsor ID
- CDC-NCEZID-6102
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 31 Jul 2015 (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.
In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections, self-reported fever, and skin infections in children <2 years old.
Detailed description
In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections (ARIs), self-reported fever, and skin infections in children <2 years old.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison | No intervention | –Hand hygiene education. |
| Intervention | Experimental | Other: Antimicrobial Hand TowelHand hygiene education and 4 antimicrobial hand towels |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mother of a child <2 years old
Key exclusion criteria (3 listed)
- Inaccessible enumeration area in the rainy season
- Multiple eligible children in a single compound
- Moved between census and round 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 |
|---|---|---|
| Antimicrobial Hand TowelNovel antimicrobial hand towel. | Other | Intervention |
Primary outcome
Number of participants with diarrheal disease
Time frame: Within 48 hours of enrollment
The number of participants that experience 3 or more loose or watery stools
3 secondary outcomes
Number of participants with respiratory infections
Time frame: Within 48 hours of enrollment
Number of participants with a subjective fever
Time frame: Within 48 hours of enrollment
Number of participants with a skin infection
Time frame: Within 48 hours of enrollment
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 31 Jul 2015.
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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?
A Phase 2/3 study testing Antimicrobial Hand Towel in people with Diarrheal Diseases and Acute Respiratory Infections, run by Centers for Disease Control and Prevention.
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 1 inclusion and 3 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 31 Jul 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of participants with diarrheal disease (time frame: Within 48 hours of enrollment). 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 31 Jul 2015.