Prophylactic Activity Against MalariaPhase 1/2NCT00408369
Prophylactic Antimalarial Activity of DB289 in Volunteers
A Phase 1/2 study testing DB289 in people with Prophylactic Activity Against Malaria, run by Immtech Pharmaceuticals, Inc at 1 site in United States.
Trial summary
To evaluate the prophylactic activity of orally administered DB289 against Plasmodium falciparum in non-immune healthy volunteers who are challenged by the bite of five P. falciparum-infected Anopheles stephensi mosquitoes Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Prophylactic Activity Against Malaria
- What is being tested?
- DB289
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Nov 2007
- Phase
- Phase 1/2
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 45 years
- BMI between 19 and 30 (Appendix IV)
- Able to provide home address and phone number; work description, address, and phone number; and to provide the name, address, and phone number of a person willing and able to assist the investigators in making contact with the cognate volunteer during the study period
- Able and willing to follow-up intensively for 3 months of scheduled visits
- Post-menopausal or surgically sterilized women
- Score of 80% or more on a written exam to test malaria knowledge and comprehension of the study
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- Serum and red cells support growth of P. falciparum in vitro (Appendix V)
- Blood type A or O
- Able and willing to provide written informed consent for screening, HIV testing, and study participation-
Who cannot join
- Clinically significant abnormalities on screening examinations
- AST, ALT, bilirubin, hemoglobin, hematocrit, prothrombin time, partial thromboplastin time, or creatinine outside the limits of normal as defined at the time of testing by the Johns Hopkins Medical Laboratories
- laboratory evidence of HIV infection or active viral hepatitis
- G6PD deficiency, or hemoglobin S or C
- Significant medical illnesses requiring systemic treatment and/or hospitalization within one month of enrollment
- History of chronic medical illnesses, significant in the investigators' judgment
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- Self-described use of tobacco
- History of alcohol or drug abuse
- Use of prescribed or over-the-counter medications or nutritional supplements within two weeks of enrollment (vitamins, at or below the daily recommended dose, may be taken during the study)
- Women of childbearing potential
- Blood or plasma donation within 2 weeks of enrollment
- History of malaria or residence in a malaria-endemic area
- Allergy to mosquito bites
- Intolerance to chloroquine, Malarone, quinine, quinidine, or tetracycline
- Taken anti-infective drugs or quinine-containing beverages in the week prior to enrollment
- Currently participating in other clinical trials, participated in a drug trial within two weeks of enrollment, or plan to participate in another clinical trial within three months from challenge
- Any factors for which the investigator believes that participation of the volunteer in the study is not appropriate
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205-2186
About this study
Official title: Prophylactic Antimalarial Activity of DB289 in Volunteers Challenged With Plasmodium Falciparum
To evaluate the prophylactic activity of orally administered DB289 against Plasmodium falciparum in non-immune healthy volunteers who are challenged by the bite of five P. falciparum-infected Anopheles stephensi mosquitoes
Read the detailed description
The primary endpoint of this study is the appearance of erythrocytic parasites (parasitemia), which indicates a prophylaxis failure. Parasitemia will be sought by multiple means, including blood culture, polymerase chain reaction (PCR), Quantitative Buffy Coat (QBC) analysis, and thick and thin blood smears (detailed methods,Appendix II).
QBC and giemsa-stained blood smears will be analyzed in real time and a positive result in any one of them is sufficient to initiate chloroquine treatment. All positive QBC analyses or blood smears will be confirmed by two experienced observers. On smears, the location of parasites will be recorded using a stage micrometer, and slides will be archived and available for later re-examination. PCR samples will be collected and stored for later analysis; cultures will be inoculated at once and maintained for 70 days.
A positive result in any one of these tests constitutes a drug failure.
- Conditions
- Prophylactic Activity Against Malaria
- Being tested
- DB289
- Keywords
- prophylactic, malaria, challenge
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB289Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is the appearance of erythrocytic parasites
(parasitemia), which indicates a prophylaxis failure. Parasitemia will be sought by
multiple means, including blood culture, polymerase chain reaction (PCR), Quantitative
Buffy Coat (QBC) analysis, and thick and thin blood smears (detailed methods,
Appendix II).
Secondary outcomes (3)
To distinguish the mechanism of prophylaxis: causal vs suppressive
To evaluate the pharmacokinetics of DB289 and DB75
To assess the safety of DB289
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prophylactic Activity Against MalariaStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immtech Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Theresa A. Shapiro, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408369
- Sponsor's protocol ID
- C06-015
- Status last verified
- Jan 2008
- First submitted
- 4 Dec 2006
- Last updated
- 29 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antimalarial Activity of DB289 in Volunteers Challenged With Plasmodium Falciparum
- ClinicalTrials.gov ID
- NCT00408369
- Acronym / sponsor ID
- C06-015
- Conditions
- Prophylactic Activity Against Malaria
- Keywords
- prophylactic, malaria, challenge
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Immtech Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 6 Dec 2006 (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.
To evaluate the prophylactic activity of orally administered DB289 against Plasmodium falciparum in non-immune healthy volunteers who are challenged by the bite of five P. falciparum-infected Anopheles stephensi mosquitoes
Detailed description
The primary endpoint of this study is the appearance of erythrocytic parasites (parasitemia), which indicates a prophylaxis failure. Parasitemia will be sought by multiple means, including blood culture, polymerase chain reaction (PCR), Quantitative Buffy Coat (QBC) analysis, and thick and thin blood smears (detailed methods,Appendix II).
QBC and giemsa-stained blood smears will be analyzed in real time and a positive result in any one of them is sufficient to initiate chloroquine treatment. All positive QBC analyses or blood smears will be confirmed by two experienced observers. On smears, the location of parasites will be recorded using a stage micrometer, and slides will be archived and available for later re-examination. PCR samples will be collected and stored for later analysis; cultures will be inoculated at once and maintained for 70 days.
A positive result in any one of these tests constitutes a drug failure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age between 18 and 45 years
- BMI between 19 and 30 (Appendix IV)
- Able to provide home address and phone number; work description, address, and phone number; and to provide the name, address, and phone number of a person willing and able to assist the investigators in making contact with the cognate volunteer during the study period
- Able and willing to follow-up intensively for 3 months of scheduled visits
- Post-menopausal or surgically sterilized women
Key exclusion criteria (17 listed)
- Clinically significant abnormalities on screening examinations
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 |
|---|---|---|
| DB289 | Drug | – |
Primary outcome
The primary endpoint of this study is the appearance of erythrocytic parasites
(parasitemia), which indicates a prophylaxis failure. Parasitemia will be sought by
multiple means, including blood culture, polymerase chain reaction (PCR), Quantitative
Buffy Coat (QBC) analysis, and thick and thin blood smears (detailed methods,
Appendix II).
3 secondary outcomes
To distinguish the mechanism of prophylaxis: causal vs suppressive
To evaluate the pharmacokinetics of DB289 and DB75
To assess the safety of DB289
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 29 Jan 2008.
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.
Theresa A. Shapiro, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DB289 in people with Prophylactic Activity Against Malaria, run by Immtech Pharmaceuticals, Inc at 1 site in United States.
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 9 inclusion and 17 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 29 Jan 2008. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 primary endpoint of this study is the appearance of erythrocytic parasites. The study lists 5 primary outcomes in all. 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 29 Jan 2008.