Amebic Liver AbscessNCT00641992
Prognosis of Failure Treatment of Amebic Liver Abscess
An observational study of Amebic Liver Abscess, run by Universidad Autonoma de San Luis Potosí at 2 sites in Mexico.
Trial summary
Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually the factors for predicting failure in the medical treatment are not clear. We conducted trial for determining the clinical value of paraclinical factor in this issue. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Amebic Liver Abscess
- How many people
- 40 participants
- Where
- 2 sitesMexico
- Study dates
- May 1999to Apr 2000
- Phase
- Observational
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: sequential patients with clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess
Who may be able to join
- Clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess.
- Both genders
- Older 15 years
Who cannot join
- Clinically suspected piogenous liver abscess
- Positive hemoculture
- Negative ELISA for amoebic antigens
- Immunosupresion (HIV)
- Abdominal or biliary surgery antecedents
- Abdominal neoplasia antecedents
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Department of Surgery, Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán".
Mexico City, Mexico DF
Faculty of Medicine, Universidad Autónoma de San Luis Potosí
San Luis Potosí City, San Luis Potosí, 78210
About this study
Official title: Prognosis Factors of the Response After Medical Treatment of Amebic Liver Abscess
Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually the factors for predicting failure in the medical treatment are not clear. We conducted trial for determining the clinical value of paraclinical factor in this issue.
- Conditions
- Amebic Liver Abscess
- Keywords
- amebic liver abscess, failure, prognosis
- Medical subject headings
- Liver Abscess, Amebic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Response to medical treatment | |
| 2 | Failure to medical treatment (surgery or percutaneous resolution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of medical treatment
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startMay 1999
- Primary completionApr 2000
- Study completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amebic Liver AbscessStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Hospital Central "Dr. Ignacio Morones Prieto"
- Investigators
- Martín Sánchez-Aguilar 1, MSc, Principal investigator, 1. Department of Experimental Surgery, Faculty of Medicine, Universidad Autónoma de San Luis PotosíOnofre Morán-Mendoza, PhD, Study director, Department of Clinical Epidemiology, Faculty of Medicine, Universidad Autónoma de San Luis Potosí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641992
- Sponsor's protocol ID
- PFP-ALA
- Status last verified
- Mar 2008
- First submitted
- 12 Mar 2008
- Last updated
- 24 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Factors of the Response After Medical Treatment of Amebic Liver Abscess
- ClinicalTrials.gov ID
- NCT00641992
- Acronym / sponsor ID
- PFP-ALA
- Conditions
- Amebic Liver Abscess
- Keywords
- amebic liver abscess, failure, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Hospital Central "Dr. Ignacio Morones Prieto"
- Study start
- May 1999
- Primary completion
- Apr 2000 (actual)
- Study completion
- Apr 2000 (actual)
- First posted
- 24 Mar 2008 (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.
Amebic liver abscess is the most frequent extra-intestinal form of the amoebiasis; actually the factors for predicting failure in the medical treatment are not clear. We conducted trial for determining the clinical value of paraclinical factor in this issue.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Response to medical treatment |
| 2 | – | –Failure to medical treatment (surgery or percutaneous resolution) |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- sequential patients with clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess
Key inclusion criteria (3 listed)
- Clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess.
- Both genders
- Older 15 years
Key exclusion criteria (6 listed)
- Clinically suspected piogenous liver abscess
- Positive hemoculture
- Negative ELISA for amoebic antigens
- Immunosupresion (HIV)
- Abdominal or biliary surgery antecedents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Failure of medical treatment
Time frame: Day 4
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 24 Mar 2008.
Related trials for Amebic Liver Abscess
Not yet recruitingPhase 3
Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess
Liver Abscess, Amoebic Liver Abscess
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.
Martín Sánchez-Aguilar 1, MSc principal investigator
1. Department of Experimental Surgery, Faculty of Medicine, Universidad Autónoma de San Luis Potosí
Onofre Morán-Mendoza, PhD study director
Department of Clinical Epidemiology, Faculty of Medicine, Universidad Autónoma de San Luis Potosí
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amebic Liver Abscess, run by Universidad Autonoma de San Luis Potosí at 2 sites in Mexico.
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 3 inclusion and 6 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 24 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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?
Failure of medical treatment (time frame: Day 4). 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 24 Mar 2008.