MalariaNCT00229775
Efficacy of Chloroquine + Sulfadoxine Pyrimethamine Versus Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines
A study testing artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamine in people with Malaria, run by Centers for Disease Control and Prevention at 3 sites in Philippines.
Trial summary
The purpose of this study is to determine whether artemether + lumefantrine is as effective as chloroquine + sulfadoxine pyrimethamine in the treatment of uncomplicated Plasmodium falciparum malaria Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malaria
- What is being tested?
- artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamine
- How many people
- 560 participants
- Where
- 3 sitesPhilippines
- Study dates
- Jul 2003to Jul 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Weight > 10 kg;
- Documented fever (axillary temperature >37.5oC) and/or a history of fever during the previous 24 hours in the absence of another obvious cause of fever (such as pneumonia, measles, otitis media);
- Monoinfection with P. falciparum between 1,000 and 100,000 asexual parasites/µl as determined by microscopic examination of thick, or thick and thin peripheral blood smears;
- Informed consent from the patient or parent/guardian (in the case of children),assent from child (ages 8 -17 years inclusive);
- Willingness on the part of the patient to return to the clinic for regular check-ups during the 28-day follow-up period.
Who cannot join
- 1. Danger signs: unable to drink or breastfeed; vomiting (more than twice in the previous 24 hours); recent history of convulsions (one or more in the previous 24 hours); impaired consciousness; unable to sit or stand; 2. Severe Manifestations of P. falciparum malaria in adults and children (World Health Organization criteria)
- Prostration (inability to sit unassisted [children], extreme weakness [adults])
- Impaired consciousness (Blantyre coma scale [children], Glascow coma scale [adults])
- Respiratory distress (sustained nasal flaring, indrawing, Kussmaul breathing)
- Multiple convulsions (³2 convulsions/24 hour period)
- Circulatory collapse (hypotension and poor perfusion)
Show all 15Show fewer
- Pulmonary edema
- Abnormal bleeding
- Jaundice
- Hemoglobinuria
- Severe anemia (Hb < 5 gm/dL)
- Hypoglycemia (blood glucose < 2.2 mmol/L [<40 mg/dL])
- Acidosis (bicarbonate <15 mmol/L)
- Hyperparisitemia (level varies with endemicity)
- Renal impairment (urine output < 12 mL/kg/24 hours) 3. Other underlying chronic or severe diseases (e.g., cardiac, renal, hepatic diseases, HIV/AIDS, malnutrition); 4. History of hypersensitivity reactions to any of the drugs being tested or used as alternative treatment: sulfonamides, chloroquine, artemisinins, artemether, lumefantrine, quinine or tetracycline/clindamycin; 4. Pregnancy (history of pregnancy or a positive urine pregnancy test); 5. Women who are breast feeding children less than 8 weeks of age. -
Trial locations and contacts
3 sites in 1 country.
Philippines3 sites
Davao Health Center
Davao City, Mindinao
Palawan Health Center
Puerto Princesa City, Palawan
Kalinga Health Center
Tabuk, Kalinga Province
About this study
The purpose of this study is to determine whether artemether + lumefantrine is as effective as chloroquine + sulfadoxine pyrimethamine in the treatment of uncomplicated Plasmodium falciparum malaria
Read the detailed description
Background: In the Philippines, close to 11 million people in 65 provinces are at risk for acquiring malaria infections. It is still one of the ten leading causes of morbidity nationwide. Each day, roughly 150-200 people fall ill with malaria. In the past 40 years, the mortality rate stabilized at around 2/100,000 population. Of those people who have malaria, approximately 1% die per year. Malaria remains one of the major causes of death in provinces such as Palawan, Isabela, Tawi-tawi, Sulu and Butuan City. Approximately 70% of all malaria in the Philippines is Plasmodium falciparum with the remaining species being P. vivax.
Recently the Department of Health (DOH) instituted a change in the national antimalarial drug guidelines changing from using chloroquine (CQ) and sulfadoxine pyrimethamine (SP) monotherapy as first and second line drugs, respectively, to a combined chloroquine plus sulfadoxine-pyrimethamine as first-line treatment, and artemether-lumefantrine (Coartem) as second line treatment. This change was made due to increasing levels of drug resistance to the previous first and second-line therapies. In order to have an improved understanding of the trends of antimalarial drug resistance in the Philippines, the DOH is initiating a sentinel surveillance system for monitoring of antimalarial drug resistance. Three sites have been selected to be representative of the country.
Objective: To establish a sentinel surveillance system to assess the efficacy of chloroquine plus sulfadoxine-pyrimethamine versus artemether + lumefantrine for the treatment of uncomplicated P. falciparum infections in three areas of the Republic of the Philippines.
Methods: An in vivo antimalarial drug efficacy trial will be conducted in three areas of the Philippines. Subjects > 6 months of age with parasitologically confirmed, uncomplicated P. falciparum infections will be recruited. Patients will be treated with single dose SP (25 mg/kg of the sulfadoxine component in a single dose) plus CQ (25 mg/kg over three days) or artemether + lumefantrine (twice daily) over 3 days. Patients will be randomly assigned one of the two drugs regimens. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Results from this study will be used to assist the DOH in assessing their national malaria treatment policy for P. falciparum malaria.
- Conditions
- Malaria
- Being tested
- artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamine
- Keywords
- Plasmodium falciparum malaria, malaria, artemether lumafantrine, chloroquine, sulfadoxine pyrimethamine, Coartem
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
Secondary outcomes (1)
Hemoglobin levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Department of Health, Philippines
- Responsible party
- Sponsor
- Investigators
- Dorin Bustos, MD, PhD, Study director, RITM, DOH, Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229775
- Sponsor's protocol ID
- CDC-NCID-3913
- Other IDs
- U30/CCU317876-01
- Status last verified
- Sep 2012
- First submitted
- 28 Sep 2005
- Last updated
- 11 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chloroquine + Sulfadoxine Pyrimethamine Versus Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines
- ClinicalTrials.gov ID
- NCT00229775
- Acronym / sponsor ID
- CDC-NCID-3913
- Conditions
- Malaria
- Keywords
- Plasmodium falciparum malaria, malaria, artemether lumafantrine, chloroquine, sulfadoxine pyrimethamine, Coartem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Department of Health, Philippines
- Study start
- Jul 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 30 Sep 2005 (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 whether artemether + lumefantrine is as effective as chloroquine + sulfadoxine pyrimethamine in the treatment of uncomplicated Plasmodium falciparum malaria
Detailed description
Background: In the Philippines, close to 11 million people in 65 provinces are at risk for acquiring malaria infections. It is still one of the ten leading causes of morbidity nationwide. Each day, roughly 150-200 people fall ill with malaria. In the past 40 years, the mortality rate stabilized at around 2/100,000 population. Of those people who have malaria, approximately 1% die per year. Malaria remains one of the major causes of death in provinces such as Palawan, Isabela, Tawi-tawi, Sulu and Butuan City. Approximately 70% of all malaria in the Philippines is Plasmodium falciparum with the remaining species being P. vivax.
Recently the Department of Health (DOH) instituted a change in the national antimalarial drug guidelines changing from using chloroquine (CQ) and sulfadoxine pyrimethamine (SP) monotherapy as first and second line drugs, respectively, to a combined chloroquine plus sulfadoxine-pyrimethamine as first-line treatment, and artemether-lumefantrine (Coartem) as second line treatment. This change was made due to increasing levels of drug resistance to the previous first and second-line therapies. In order to have an improved understanding of the trends of antimalarial drug resistance in the Philippines, the DOH is initiating a sentinel surveillance system for monitoring of antimalarial drug resistance. Three sites have been selected to be representative of the country.
Objective: To establish a sentinel surveillance system to assess the efficacy of chloroquine plus sulfadoxine-pyrimethamine versus artemether + lumefantrine for the treatment of uncomplicated P. falciparum infections in three areas of the Republic of the Philippines.
Methods: An in vivo antimalarial drug efficacy trial will be conducted in three areas of the Philippines. Subjects > 6 months of age with parasitologically confirmed, uncomplicated P. falciparum infections will be recruited. Patients will be treated with single dose SP (25 mg/kg of the sulfadoxine component in a single dose) plus CQ (25 mg/kg over three days) or artemether + lumefantrine (twice daily) over 3 days. Patients will be randomly assigned one of the two drugs regimens. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Results from this study will be used to assist the DOH in assessing their national malaria treatment policy for P. falciparum malaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Weight > 10 kg;
- Documented fever (axillary temperature >37.5oC) and/or a history of fever during the previous 24 hours in the absence of another obvious cause of fever (such as pneumonia, measles, otitis media);
- Monoinfection with P. falciparum between 1,000 and 100,000 asexual parasites/µl as determined by microscopic examination of thick, or thick and thin peripheral blood smears;
- Informed consent from the patient or parent/guardian (in the case of children),assent from child (ages 8 -17 years inclusive);
- Willingness on the part of the patient to return to the clinic for regular check-ups during the 28-day follow-up period.
Key exclusion criteria (15 listed)
- 1. Danger signs: unable to drink or breastfeed; vomiting (more than twice in the previous 24 hours); recent history of convulsions (one or more in the previous 24 hours); impaired consciousness; unable to sit or stand; 2. Severe Manifestations of P. falciparum malaria in adults and children (World Health Organization criteria)
- Prostration (inability to sit unassisted [children], extreme weakness [adults])
- Impaired consciousness (Blantyre coma scale [children], Glascow coma scale [adults])
- Respiratory distress (sustained nasal flaring, indrawing, Kussmaul breathing)
- Multiple convulsions (³2 convulsions/24 hour period)
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 |
|---|---|---|
| artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamine | Drug | – |
Primary outcome
Clinical cure
1 secondary outcome
Hemoglobin levels
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 11 Sep 2012.
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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.
Dorin Bustos, MD, PhD study director
RITM, DOH, Philippines
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artemether/lumafantrine vs chloroquine/sulfadoxine-pyrimethamine in people with Malaria, run by Centers for Disease Control and Prevention at 3 sites in Philippines.
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 15 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 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Philippines. 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?
Clinical cure. 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 11 Sep 2012.