Malaria, VivaxNCT00951106
Therapeutic Efficacy Study of Pyrimethamine/Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
A study testing Pyrimethamine/sulfdoxine (Fansidar) in people with Malaria, Vivax and Malaria, Falciparum, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in Peru.
Trial summary
The purpose of this study is to determine the efficacy of pyrimethamine/sulfdoxine (Fansidar®) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon. Reports in the mid 1990s indicated that Fansidar was failing to cure patients with confirmed falciparum malaria. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Malaria, Vivax, Malaria, Falciparum
- What is being tested?
- Pyrimethamine/sulfdoxine (Fansidar)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 sitePeru
- Study dates
- Jan 1998to Aug 2009
- Phase
- Interventional
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pf monoinfection with asexual forms
- Parasite density of greater than 500 per mcl and less than 200 parasites per oil immersion field (MINSA quantification of "4 plus")
- Age > 6 months
- Temperature greater than 38C (101F)
- Available and willing to return for follow-up
Who cannot join
- Presence of any of the following "danger" signs or symptoms suggestive of severe malaria
- Not able to drink or breastfeed
- Repeated vomiting (unable to keep anything down)
- Convulsions during present illness
- Lethargic or unconscious state
- Unable to sit or stand up
Show all 13Show fewer
- Respiratory distress
- Jaundice (observation) or dark urine (by history)
- Severe anemia (Hemoglobin < 5 g/dl)
- Hypotension (systolic BP < 80 mm Hg in adults and < 50 mm Hg in children under the age of 5
- Presence of another significant illness or chronic disease
- Known pregnancy (by history)
- History of hypersensitivity to medication used in the test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Efficacy Study of Pyrimethamine / Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
The purpose of this study is to determine the efficacy of pyrimethamine/sulfdoxine (Fansidar®) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon. Reports in the mid 1990s indicated that Fansidar was failing to cure patients with confirmed falciparum malaria. The study design was based on accepted WHO parasitological and clinical outcomes to determine the overall efficacy of Fansider and inform the Peruvian National Malaria Control authorities as to the continued wisdom of recommending Fansidar as first line treatment for uncomplicated falciparum malaria in the Peruvian Amazon.
- Conditions
- Malaria, Vivax, Malaria, Falciparum
- Being tested
- Pyrimethamine/sulfdoxine (Fansidar)
- Keywords
- Peru, Sulfadoxine-pyrimethamine, Drug resistance
- Medical subject headings
- Malaria, Vivax, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrimethamine/sulfdoxine (Fansidar)Drug
| Study group | Role | What they receive |
|---|---|---|
| Pyrimethamine/sulfdoxine (Fansidar) | Experimental | Pyrimethamine/sulfdoxine (Fansidar) Receives: Drug: Pyrimethamine/sulfdoxine (Fansidar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.
Measured: 28 days after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJan 1998
- Primary completionJun 1999
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malaria, VivaxStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Investigators
- Alan Magill, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951106
- Sponsor's protocol ID
- WRAIR #719
- Status last verified
- Jul 2010
- First submitted
- 30 Jul 2009
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Magill AJ, Zegarra J, Garcia C, Marquino W, Ruebush TK 2nd. Efficacy of sulfadoxine-pyrimethamine and mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria in the Amazon basin of Peru. Rev Soc Bras Med Trop. 2004 May-Jun;37(3):279-81. doi: 10.1590/s0037-86822004000300015.
PubMed 15330070Huaman MC, Roncal N, Nakazawa S, Long TT, Gerena L, Garcia C, Solari L, Magill AJ, Kanbara H. Polymorphism of the Plasmodium falciparum multidrug resistance and chloroquine resistance transporter genes and in vitro susceptibility to aminoquinolines in isolates from the Peruvian Amazon. Am J Trop Med Hyg. 2004 May;70(5):461-6.
PubMed 15155976Bacon DJ, Tang D, Salas C, Roncal N, Lucas C, Gerena L, Tapia L, Llanos-Cuentas AA, Garcia C, Solari L, Kyle D, Magill AJ. Effects of point mutations in Plasmodium falciparum dihydrofolate reductase and dihydropterate synthase genes on clinical outcomes and in vitro susceptibility to sulfadoxine and pyrimethamine. PLoS One. 2009 Aug 26;4(8):e6762. doi: 10.1371/journal.pone.0006762.
PubMed 19707564
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy Study of Pyrimethamine / Sulfdoxine (Fansidar®) for the Treatment of Uncomplicated Falciparum Malaria in the Peruvian Amazon
- ClinicalTrials.gov ID
- NCT00951106
- Acronym / sponsor ID
- WRAIR #719
- Conditions
- Malaria, Vivax, Malaria, Falciparum
- Keywords
- Peru, Sulfadoxine-pyrimethamine, Drug resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Study start
- Jan 1998
- Primary completion
- Jun 1999 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Aug 2009 (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.
The purpose of this study is to determine the efficacy of pyrimethamine/sulfdoxine (Fansidar®) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon. Reports in the mid 1990s indicated that Fansidar was failing to cure patients with confirmed falciparum malaria. The study design was based on accepted WHO parasitological and clinical outcomes to determine the overall efficacy of Fansider and inform the Peruvian National Malaria Control authorities as to the continued wisdom of recommending Fansidar as first line treatment for uncomplicated falciparum malaria in the Peruvian Amazon.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrimethamine/sulfdoxine (Fansidar) | Experimental | Drug: Pyrimethamine/sulfdoxine (Fansidar)Pyrimethamine/sulfdoxine (Fansidar) |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pf monoinfection with asexual forms
- Parasite density of greater than 500 per mcl and less than 200 parasites per oil immersion field (MINSA quantification of "4 plus")
- Age > 6 months
- Temperature greater than 38C (101F)
- Available and willing to return for follow-up
Key exclusion criteria (13 listed)
- Presence of any of the following "danger" signs or symptoms suggestive of severe malaria
- Not able to drink or breastfeed
- Repeated vomiting (unable to keep anything down)
- Convulsions during present illness
- Lethargic or unconscious state
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 |
|---|---|---|
| Pyrimethamine/sulfdoxine (Fansidar) | Drug | Pyrimethamine/sulfdoxine (Fansidar) |
Primary outcome
Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon.
Time frame: 28 days after dose
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 27 Jul 2010.
- Results publication: PubMed 15330070Magill AJ, Zegarra J, Garcia C, Marquino W, Ruebush TK 2nd. Efficacy of sulfadoxine-pyrimethamine and mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria in the Amazon basin of Peru. Rev Soc Bras Med Trop. 2004 May-Jun;37(3):279-81. doi: 10.1590/s0037-86822004000300015.
- Results publication: PubMed 15155976Huaman MC, Roncal N, Nakazawa S, Long TT, Gerena L, Garcia C, Solari L, Magill AJ, Kanbara H. Polymorphism of the Plasmodium falciparum multidrug resistance and chloroquine resistance transporter genes and in vitro susceptibility to aminoquinolines in isolates from the Peruvian Amazon. Am J Trop Med Hyg. 2004 May;70(5):461-6.
- Derived from this study: PubMed 19707564Bacon DJ, Tang D, Salas C, Roncal N, Lucas C, Gerena L, Tapia L, Llanos-Cuentas AA, Garcia C, Solari L, Kyle D, Magill AJ. Effects of point mutations in Plasmodium falciparum dihydrofolate reductase and dihydropterate synthase genes on clinical outcomes and in vitro susceptibility to sulfadoxine and pyrimethamine. PLoS One. 2009 Aug 26;4(8):e6762. doi: 10.1371/journal.pone.0006762.
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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.
Alan Magill, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyrimethamine/sulfdoxine (Fansidar) in people with Malaria, Vivax and Malaria, Falciparum, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in Peru.
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 5 inclusion and 13 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 27 Jul 2010. 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 Peru. 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?
Determine the efficacy of pyrimethamine/sulfdoxine (Fansidar) for the treatment of uncomplicated falciparum malaria in the Peruvian Amazon. (time frame: 28 days after dose). 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 NCT00951106, which also lists 3 linked publications.
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 27 Jul 2010.