Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan
Brief Summary: In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.


Options:
A: Inclusion criteria:

* Acute, uncomplicated P.falciparum malaria, microscopically confirmed
* Temperature at screening of 37.5oC or or more or confirmed history of fever within previous 24 hours
* Weigh 7.5kg or over
* Screening haemoglobin (Hb) of 7g/dl or over, or haematocrit of 25% or more(If Hb not available at screening)
* Willingness to comply with the study visits and procedures, as outlined in the informed consent form
* Written or oral witnessed consent has been obtained from parent or guardian
* Assent is given by a child aged 12 years or over, in addition to the consent of their parent or guardian

Exclusion criteria:

* Features of severe/complicated falciparum malaria
* Hypersensitivity to active substances (chlorproguanil, dapsone, artesunate, artemether, lumefantrine)
* Known allergy to biguanides, sulphones, sulphonamides, artemisinin derived products or aminoalcohol drugs
* Known history of G6PD deficiency
* Infants with a history of hyperbilirubinaemia during the neonatal period
* Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the WHO (World Health Organization) list of essential drugs
* Evidence of any concomitant infection at the time of presentation (including P. vivax, P. ovale and P. malariae)
* Any other underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis, bacterial infection; cardiac or pulmonary disease)
* Malnutrition, defined as a child whose weight-for-height is below -3 standard deviations or less than 70% of the median of the NCHS/WHO normalised reference values
* Treatment within the past three months with mefloquine or mefloquine-sulphadoxine-pyrimethamine; twenty-eight days with sulphadoxine/pyrimethamine, sulfalene/pyrimethamine, lumefantrine or artemether/lumefantrine, amodiaquine, atovaquone or atovoquone/proguanil, halofantrine; 14-days with chlorproguanil/dapsone, or 7-days with quinine (full course), proguanil, artemisinins, tetracycline doxycycline or clindamycin
* Positive sulphadoxine/pyrimethamine urine screen for 'unknown' antimalarial drug use in prior 28-days
* Use of an investigational drug within 30 days or 5 half-lives whichever is the longer
* Previous participation in this study
* Female subjects of child-bearing age, who have had a positive pregnancy test at screening, or do not give their consent to take a pregnancy test
* Female subjects who will be breast-feeding an infant for the duration of the study
B: Inclusion Criteria:

* presentation at basic health unit with suspected clinical malaria
* mono-infection infection with P. falciparum confirmed by microscopy
* over 2 years of age (no upper age restriction)
* weight over 5 kg (no upper weight restriction)
* if of child bearing age then non-pregnant and willing to remain so for the duration of the study
* greater than 1 asexual parasite per 10 fields
* understands and is willing to sign the consent form
* a resident in the study site willing to collaborate for a full period of follow-up
* no signs of severe malaria

Exclusion Criteria:

* other serious disease (e.g., cardiac, renal or hepatic)
* in women of child bearing age, pregnancy
* allergy to any of the study drugs or related compounds
* reports to have used any malaria drugs in the last 21 days
* other species of malaria seen
* signs of severe malaria
C: Inclusion criteria:

* Acute, uncomplicated P.falciparum malaria, microscopically confirmed infection.
* Temperature at screening of 37.5oC or over or confirmed history of fever within previous 24-hours.
* Weight 7.5kg or over , no upper weight limit.
* Screening haemoglobin (Hb) of 7g/dl, or more or haematocrit of 25% or over(if Hb not available at screening).
* Willingness to comply with the study visits and procedures, as outlined in the informed consent form.
* Written or oral witnessed consent obtained from subject, parent or guardian.
* Assent is given by a child aged 12 to \<18years, in addition to the consent of their parent or guardian.

Exclusion criteria:

* Features of severe/complicated falciparum malaria.
* Hypersensitivity to active substances (chlorproguanil, dapsone, artesunate), or excipients of the investigational products.
* Known allergy to biguanides, sulphones, sulphonamides or artemisinin derived products.
* Known history of G6PD deficiency.
* Infants with a history of hyperbilirubinaemia during the neonatal period.
* Evidence of any concomitant infection at the time of presentation (including P. vivax, P. ovale and P. malariae).
* Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the WHO (World Health Organization) list of essential drugs.
* Any other underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis, bacterial infection; cardiac or pulmonary disease).
* Malnutrition, defined as a child whose weight-for-height is below -3 standard deviations or less than 70% of the median of the NCHS/WHO normalised reference values
* Treatment within the past three months with mefloquine or mefloquine-sulphadoxine-pyrimethamine; twenty-eight days with sulphadoxine/pyrimethamine, sulfalene/pyrimethamine, lumefantrine or artemether/lumefantrine, amodiaquine, atovaquone or atovaquone/proguanil, halofantrine; 14-days with chlorproguanil/dapsone, or 7-days with quinine (full course), proguanil, artemisinin, tetracycline doxycycline or clindamycin.
* Positive sulphadoxine/pyrimethamine urine screen for 'unknown' antimalarial drug use in prior 28-days.
* Use of an investigational drug within 30 days or 5 half-lives whichever is the longer.
* Previous participation in this study.
* Female subjects of child-bearing potential who have had a positive pregnancy test at enrolment, or do not give their consent to take a pregnancy test.
* Female subjects who will be breast-feeding an infant for the duration of the study.
D: Inclusion Criteria:

* infection with P.falciparum detected by PCR

Exclusion Criteria:

* pregnancy
* severe anaemia
* fever or other signs of illness
* history of allergy to sulfa drugs
* presence of other species of Plasmodium detected by microscopy

Answer: D