DientamoebiasisPhase 4DFPTNCT01314976
Treatment Study of Metronidazole to Treat Dientamoebiasis in Children
A Phase 4 study testing Metronidazole in people with Dientamoebiasis, run by Statens Serum Institut at 1 site in Denmark.
Trial summary
Introduction: Dientamoeba fragilis (DF) is a commonly occurring intestinal protozoan that is considered a possible cause of infectious gastrointestinal disease in adults and children. DF has a particular high prevalence in children, and it is suspected that children present more symptoms in infection than adults. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Dientamoebiasis
- What is being tested?
- Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2011to Jun 2013
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with samples investigated at Statens Serum Institut.
- Faecal sample (index) positive for Dientamoeba fragilis (DF) by realtime PCR, within < 7 days.
- No faecal samples positive for DF within the period: 3 months prior to and up to index-sample.
- Telephone interview to parents no later then 14 days after result from index-sample.
- Age 3-12 years old.
- Place of residence: Island of Zealand, incl. capital region.
- Symptoms consistent with gastrointestinal infection of DF: Either 1) ≥ 2 episodes of diarrhea per week or 2) ≥ 2 episodes of stomach ache per week or 3) ≥ 2 of the following symptoms: Anorexia, Failure to thrive, Anal itching, excessive flatulence, other change in bowel movements.
Who cannot join
- Expected non-compliance.
- Objection to subject participation from referring physician.
- Underlying illness or comorbidity, incl. known gastrointestinal illness (both infectious and non-infectious), but excluding constipation.
- Known liver disease or intolerance/allergy to metronidazole.
- Positive screening for other intestinal pathogens, which may explain subject symptoms.
- Treatment with metronidazole outside of study within study period.
- Weight > 50 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metronidazole for the Treatment of Dientamoebiasis in Children in Denmark - A Randomized, Placebo-controlled, Double-blinded Clinical Trial
Introduction: Dientamoeba fragilis (DF) is a commonly occurring intestinal protozoan that is considered a possible cause of infectious gastrointestinal disease in adults and children. DF has a particular high prevalence in children, and it is suspected that children present more symptoms in infection than adults. However, evidence of causality is lacking, treatment regimens are largely untested in controlled trials, and the most commonly used antibiotic against DF in Denmark, metronidazole, has never been tested against placebo.
Main objective: To determine the clinical effect of metronidazole in DF-infected children with gastrointestinal complaints, where no other aetiology is known and no other gastrointestinal pathogens could be shown.
- Conditions
- Dientamoebiasis
- Being tested
- Metronidazole, Placebo
- Keywords
- Children, parasite, intestinal, treatment, RCT
- Medical subject headings
- Dientamoebiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl® (Metronidazole), oral suspension. Sanofi-aventis, ATC-code: P01AB01
Metronidazole, oral suspension, 40mg/ml.
1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents.
PlaceboDrug
Placebo.
1 treatment period of 1ml/kg/day for 10 days, 3 daily dosages. Administered by parents.
Placebo formulation is identical to Flagyl® (Metronidazole), oral suspension from Sanofi-Aventis.
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Experimental | Active treatment. Receives: Drug: Metronidazole |
| Placebo | Placebo comparator | Passive treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall gastrointestinal symptoms, day 14
All participants receive 10 days of treatment with study drug (placebo or active). Primary outcome measure is registered on day 14 after end of treatment, using a questionnaire for the parents of the study participant.
Measuring will be done using a VAS-score scale, addressing overall level of gastrointestinal symptoms in the previous 14 days. Results will be noted as a value from 0 to 10.
Measured: 14 days after end of treatment period
Secondary outcomes (1)
Realtime PCR for D. fragilis, day 14
Secondary outcome measure will be registered using a specific realtime PCR for D. fragilis, performed on faecal samples collected from study-participant.
Results will be noted as either positive or negative.
Measured: Sample collection 14 days after end of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DientamoebiasisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Roser, Statens Serum Institut
- Investigators
- Dennis Röser, MD, Principal investigator, Statens Serum InstitutDennis Röser, MD, Study director, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314976
- Sponsor's protocol ID
- DSR-01
- Other IDs
- 2010-024657-36
- Acronym
- DFPT
- Status last verified
- Jun 2013
- First submitted
- 14 Mar 2011
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roser D, Simonsen J, Stensvold CR, Olsen KE, Bytzer P, Nielsen HV, Molbak K. Metronidazole therapy for treating dientamoebiasis in children is not associated with better clinical outcomes: a randomized, double-blinded and placebo-controlled clinical trial. Clin Infect Dis. 2014 Jun;58(12):1692-9. doi: 10.1093/cid/ciu188. Epub 2014 Mar 18.
PubMed 24647023
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metronidazole for the Treatment of Dientamoebiasis in Children in Denmark - A Randomized, Placebo-controlled, Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT01314976
- Acronym / sponsor ID
- DFPT / DSR-01
- Conditions
- Dientamoebiasis
- Keywords
- Children, parasite, intestinal, treatment, RCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Mar 2011 (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.
Introduction: Dientamoeba fragilis (DF) is a commonly occurring intestinal protozoan that is considered a possible cause of infectious gastrointestinal disease in adults and children. DF has a particular high prevalence in children, and it is suspected that children present more symptoms in infection than adults. However, evidence of causality is lacking, treatment regimens are largely untested in controlled trials, and the most commonly used antibiotic against DF in Denmark, metronidazole, has never been tested against placebo.
Main objective: To determine the clinical effect of metronidazole in DF-infected children with gastrointestinal complaints, where no other aetiology is known and no other gastrointestinal pathogens could be shown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Experimental | Drug: MetronidazoleActive treatment. |
| Placebo | Placebo comparator | Drug: PlaceboPassive treatment. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients with samples investigated at Statens Serum Institut.
- Faecal sample (index) positive for Dientamoeba fragilis (DF) by realtime PCR, within < 7 days.
- No faecal samples positive for DF within the period: 3 months prior to and up to index-sample.
- Telephone interview to parents no later then 14 days after result from index-sample.
- Age 3-12 years old.
Key exclusion criteria (7 listed)
- Expected non-compliance.
- Objection to subject participation from referring physician.
- Underlying illness or comorbidity, incl. known gastrointestinal illness (both infectious and non-infectious), but excluding constipation.
- Known liver disease or intolerance/allergy to metronidazole.
- Positive screening for other intestinal pathogens, which may explain subject symptoms.
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 |
|---|---|---|
| MetronidazoleAlso: Flagyl® (Metronidazole), oral suspension. Sanofi-aventis, ATC-code: P01AB01Metronidazole, oral suspension, 40mg/ml. 1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents. | Drug | Metronidazole |
| PlaceboPlacebo. 1 treatment period of 1ml/kg/day for 10 days, 3 daily dosages. Administered by parents. Placebo formulation is identical to Flagyl® (Metronidazole), oral suspension from Sanofi-Aventis. | Drug | Placebo |
Primary outcome
Overall gastrointestinal symptoms, day 14
Time frame: 14 days after end of treatment period
All participants receive 10 days of treatment with study drug (placebo or active). Primary outcome measure is registered on day 14 after end of treatment, using a questionnaire for the parents of the study participant. Measuring will be done using a VAS-score scale, addressing overall level of gastrointestinal symptoms in the previous 14 days. Results will be noted as a value from 0 to 10.
1 secondary outcome
Realtime PCR for D. fragilis, day 14
Time frame: Sample collection 14 days after end of treatment period
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 26 Jun 2013.
- Derived from this study: PubMed 24647023Roser D, Simonsen J, Stensvold CR, Olsen KE, Bytzer P, Nielsen HV, Molbak K. Metronidazole therapy for treating dientamoebiasis in children is not associated with better clinical outcomes: a randomized, double-blinded and placebo-controlled clinical trial. Clin Infect Dis. 2014 Jun;58(12):1692-9. doi: 10.1093/cid/ciu188. Epub 2014 Mar 18.
Related trials for Dientamoebiasis
Recruiting
Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults
Dientamoeba Fragilis Infection
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.
Dennis Röser, MD principal investigator
Statens Serum Institut
Dennis Röser, MD study director
Statens Serum Institut
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 Metronidazole in people with Dientamoebiasis, run by Statens Serum Institut at 1 site in Denmark.
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 7 inclusion and 7 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 26 Jun 2013. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Overall gastrointestinal symptoms, day 14 (time frame: 14 days after end of treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01314976, which also lists 1 linked publication.
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 26 Jun 2013.