Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria: a Randomized Clinical Trial
Brief Summary: Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However its administration is often not feasible due to lack of simple equipment or trained staff. When referral is not possible, a viable alternative is needed. The intrarectal route is of interest in children since it is painless and simple. Studies of the efficacy of intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.


Options:
A: Inclusion Criteria:

All children aged 12 months to 6 years in the 13 study villages will be enrolled in the study and followed up for the duration of the study. The inclusion criteria for randomization will be:

1. Children aged 12 months to 6 years; and
2. History of fever in the preceding 48 hours or a measured temperature \> 37.5oC plus asexual forms of P. falciparum in the peripheral blood film of 500/μl or above; and
3. Hb \<110g/l and \>69g/l (Our choice of the upper limit of moderate anaemia (70 - 79g/l) is to enable us assess the response to our interventions of severer forms of anaemia while at the same time reducing the risk of adverse events which might occur with lower levels of Hb).

Exclusion Criteria:

1. Refusal of parent or guardian to give consent to the child's participation in the study
2. Inability of the subjects to take oral medications
3. Presence of features of severe malaria as defined by WHO50, with the exception of anaemia and parasite density
4. Children who have urgent need for blood transfusion as indicated by the presence of tachypnoea, tachycardia \& gallop rhythm, tender hepatomegaly
5. Children with known haemoglobinopathy
6. Children with a weight for height Z score below -3SD of WHO/NCHS standard
7. Enrolment in another research project
B: 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
C: Inclusion Criteria:

1. Age: 3 months to 9 years.
2. Haemoglobin concentration 7g/dl on admission to hospital.
3. Residence within 30 km of the study centre and availability for the duration of the study period.
4. Informed consent to participate in the study given by the parent or guardian.

Exclusion Criteria:

1. Simultaneous participation in any other trial.
2. Allergy to sulpha drugs.
3. Residence \> 30 km from the recruitment site.
4. Lack of consent.
D: Inclusion Criteria:

* Children aged 6 months to 5 years admitted to Mulago hospital during the study period who satisfy the World Health Organization (WHO) case definition of cerebral malaria (Unarousable coma lasting more than 30 minutes after a seizure, with peripheral asexual P.falciparum parasitaemia and absence of other causes of coma) and whose caretakers give informed consent.

Exclusion Criteria:

* Patients with diarrhea (more than 4 motions/24 hours)
* Any recent anal pathology (such as rectal bleeding, rectal prolapse)
* Documented quinine treatment in previous 48 hours.

Answer: D