Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intermittent Screening and Treatment (IST) or Intermittent Preventive Treatment (IPT) With Dihydroartemisinin-Piperaquine, Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya: a Randomized Controlled Trial
Brief Summary: Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals in the second and third trimesters of pregnancy irrespective of the presence of malaria parasitemia, is currently recommended for HIV-negative women in all areas with stable moderate to high transmission of malaria. Due to increasing resistance to SP, it is no longer used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for IPTp, as well as to explore the strategy of intermittent screening and treatment in pregnancy (ISTp) with DP. This strategy uses increased screening at time of focused antenatal care (FANC) with treatment of women who screen positive.

The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in an area with decreasing malaria transmission and high levels of SP resistance in Kenya.


Options:
A: * INCLUSION CRITERIA (Parasite Recrudescence Study):

  1. Age 2 to 65 years, inclusive
  2. Uncomplicated P. falciparum malaria
  3. Temperature greater than or equal to 37.5 degrees Celsius or history of fever within the last 24 h
  4. P. falciparum asexual parasite density less than or equal to 200,000/microL
  5. Willingness to allow the storage of blood samples collected as part of the study
  6. Willingness and ability of patients/guardians to comply with the protocol for the duration of the study.

EXCLUSION CRITERIA (Parasite Recrudescence Study):

1. Severe malaria: diminished consciousness, respiratory distress, severe prostration, anuria, jaundice, hemoglobinuria, repetitive vomiting, or cessation of eating and drinking
2. Non-malaria etiology of febrile illness (e.g., respiratory tract infection) evident by history and physical examination
3. Hematocrit \<25%
4. Treatment of present symptoms with an antimalarial drug within the previous 7 days
5. Pregnancy or breastfeeding
6. History of allergy or known contraindication to artemisinins or MQ
7. Splenectomy
8. P. vivax parasitemia

INCLUSION CRITERIA (Peripheral Blood Collection Study):

1. Healthy-appearing adults greater than or equal to 18 years old
2. Residence in Pursat province
3. Willingness to participate in the study as evidenced by informed consent

EXCLUSION CRITERIA (Peripheral Blood Collection Study):

1. Pregnancy
2. Hematocrit \<25%
B: Inclusion Criteria:

1. Age 4 -5 months
2. Confirmed HIV status of biological mother
3. Negative HIV DNA PCR test at time of enrollment for infants born to HIV-infected mothers
4. Infants born to HIV-infected mothers must be breastfeeding
5. Residency within 30km of the study clinic
6. Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
7. Provision of informed consent by parent/guardian

Exclusion Criteria:

1. History of allergy or sensitivity to TS, SP, or DP
2. Active medical problem requiring in-patient evaluation at the time of screening
3. Intention of moving more that 30km from the study clinic during the follow-up period
4. Chronic medical condition (i.e. malignancy) requiring frequent medical attention
5. Living in the same household as a previously enrolled study participant
6. QTc interval \> 450 msec
7. Other clinically significant ECG abnormalities such as arrhythmia, ischemia, or evidence of heart failure
8. Family history of Long QT syndrome
9. Current use of drugs that prolong the QT interval
C: Inclusion Criteria:

1. Viable pregnancy assessed by Doppler
2. Gestational age 16 to 32 weeks (inclusive) by fundal height
3. No history of IPTp use during this pregnancy
4. Willing to participate and complete the study schedule
5. Willing to sign or thumb print informed consent
6. Resident of study area and intending to stay in the area for the duration of the follow-up
7. Willing to deliver in the labor ward of the study clinic or hospital
8. HIV negative at enrolment

Exclusion Criteria:

1. HIV positive or unknown
2. Residence outside study area or planning to move out in the 12 months following enrolment
3. High risk pregnancy, including any pre-existing illness likely to cause complication of pregnancy (hypertension, diabetes, asthma, epilepsy, renal disease, liver disease, fistula repair, leg or spine deformity)
4. Severe anemia requiring blood transfusion (Hb ≤ 7.0 g/dL) at enrolment
5. Known allergy or previous adverse reaction to any of the study drugs
6. Unable to give informed consent (for example due to mental disability)
7. Previous inclusion in the same study
8. Gestational age \>32 weeks
9. Previous IPTp during the current pregnancy
10. Participating in other malaria intervention studies
11. Known or suspected cardiac disease
12. Patients taking drugs in any of the following classes: antiarrhythmic agents, neuroleptics, macrolides, and certain antimalarial drugs such as mefloquine, chloroquine, halofantrine and lumefantrine.
D: Inclusion Criteria:

* Informed consent
* Permanent residence in the study area

Exclusion Criteria:

* Allergy/hypersensitivity to sulfonamides or pyrimethamine
* Signs of severe hepatic or renal dysfunction not due to malaria

Answer: C