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| Name | Class |
|---|---|
| University of Khartoum | OTHER |
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This is a randomized controlled trial to assess the efficacy and safety of the national malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine - pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. vivax malaria and the hematologic effect of 14 days routine primaquine based radical cure in patients suffering from a P. vivax or mixed infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pf: ASP | Active Comparator | In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) |
|
| Pv: ASP + 14DPQ on day 2 | Active Comparator | In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2 |
|
| Pf: ASP + SDPQ | Active Comparator | In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2 |
|
| Pv: ASP + 14DPQ on day 42 | Active Comparator | In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP | Drug | 3 days of artesunate sulfadoxine/pyrimethamine on days 0-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The recurrence of parasitaemia within 42 days of follow in P. falciparum infections | Outcome measure is presented unadjusted and adjusted for PCR and compared between P. falciparum intervention and control arm | In the first 42 days |
| The recurrence of parasitaemia within 42 days of follow in P. vivax infections | Outcome measure is presented unadjusted and adjusted for PCR and compared between P. vivax intervention and control arm | In the first 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment | Outcome measure is stratified for P. falciparum and P. vivax infections | on days 1,2,3 |
| The proportion of patients with fever on day 1, 2 and 3 after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muzamil Mahdi, PhD | University of Khartoum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Halfa Hospital | New Halfa | Kassalla | 31112 | Sudan | ||
| Gizeria Slang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29548285 | Derived | Hamid MMA, Thriemer K, Elobied ME, Mahgoub NS, Boshara SA, Elsafi HMH, Gumaa SA, Hamid T, Abdelbagi H, Basheir HM, Marfurt J, Chen I, Gosling R, Price RN, Ley B. Low risk of recurrence following artesunate-Sulphadoxine-pyrimethamine plus primaquine for uncomplicated Plasmodium falciparum and Plasmodium vivax infections in the Republic of the Sudan. Malar J. 2018 Mar 16;17(1):117. doi: 10.1186/s12936-018-2266-9. |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| SDPQ | Drug | single dose primaquine on day 2 |
|
| 14DPQ | Drug | 14 day primaquine starting on day 2 |
|
| 14DPQ on Day 42 | Drug | 14 day primaquine starting on day 42 |
|
Outcome measure is stratified for P. falciparum and P. vivax infections
| on days 1, 2, 3 |
| The proportion of patients with gametocytemia on any of the follow up dates | Outcome measure is stratified for P. falciparum and P. vivax infections | In the first 42 days |
| The proportion of patients with severe anaemia (Hb<7g/dl) or requiring blood transfusion within 42 days of enrolment | Outcome measure is stratified for P. falciparum and P. vivax infections | In the first 42 days |
| The fractional change in Hb between baseline and day 7,14 and 16 (incl. proportion of patients with >25% drop in Hb between the time points) in vivax / mixed infection patients receiving PQ | Outcome measure is stratified for P. falciparum and P. vivax infections | on days 0, 7, 14 and 16 |
| The proportion of patients with adverse and serious adverse events | Outcome measure is stratified for P. falciparum and P. vivax infections | In the first 42 days |
| The proportion of vivax patients adhering to 14 days of primaquine treatment in the vivax cohort as measured by pill count | at the end of 14DPQ treatment (day 16) |
| The distribution of G6PD activity among the study population | on day of enrolment |
| Khartoum |
| Khartoum State |
| 11111 |
| Sudan |
| D000079426 |
| Vector Borne Diseases |